CARPUJECT HOLDER

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE [OFF LABEL USE OF DEVICE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A PHARMACIST FROM MEDICAL INFORMATION TEAM AND PRODUCT QUALITY GROUP. A PATIENT (AGE AND GENDER NOT PROVIDED) RECEIVED CARPUJECT HOLDER (CARPUJECT HOLDER). THE PATIENT'S RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE OF DEVICE (NON-SERIOUS), OUTCOME "UNKNOWN", DESCRIBED AS "UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE". THE REPORTER CONSIDERED "UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE" ASSOCIATED TO CARPUJECT HOLDER. CAUSALITY FOR "UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). ADDITIONAL INFORMATION: CALLER UNABLE TO BE TRANSFERRED TO SAFETY FOR REPORTING OF OFF-LABEL USE. HCP DID NOT PROVIDE WHAT PRODUCT OR NDC THAT HAD BEEN USED WITH THE CARPUJECT IN THIS MANNER. IT WAS REPORTED RECEIVING FEEDBACK FROM CLINICIANS THAT THEY WERE UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE. THEY WERE TELLING IT CREATED TOO MUCH PRESSURE AND WILL RUIN THE ACCESS. HCP STATED, THEY HAD NOT HAD ANY QUALITY ISSUES. THEY WERE TRYING TO EXPLAIN HOW IT IS USED, THEN GETTING GREAT FEEDBACK AND IT HAD BEEN USED WITH CENTRAL LINES AND THERE WAS NO ISSUE.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE [OFF LABEL USE OF DEVICE]. NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A PHARMACIST FROM MEDICAL INFORMATION TEAM AND PRODUCT QUALITY GROUP. A PATIENT (AGE AND GENDER NOT PROVIDED) RECEIVED CARPUJECT HOLDER (CARPUJECT HOLDER). THE PATIENT'S RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE OF DEVICE (NON-SERIOUS), OUTCOME "UNKNOWN", DESCRIBED AS "UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE". THE REPORTER CONSIDERED "UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE" ASSOCIATED TO CARPUJECT HOLDER. CAUSALITY FOR "UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). ADDITIONAL INFORMATION: CALLER UNABLE TO BE TRANSFERRED TO SAFETY FOR REPORTING OF OFF-LABEL USE. HCP DID NOT PROVIDE WHAT PRODUCT OR NDC THAT HAD BEEN USED WITH THE CARPUJECT IN THIS MANNER. IT WAS REPORTED RECEIVING FEEDBACK FROM CLINICIANS THAT THEY WERE UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE. THEY WERE TELLING IT CREATED TOO MUCH PRESSURE AND WILL RUIN THE ACCESS. HCP STATED, THEY HAD NOT HAD ANY QUALITY ISSUES. THEY WERE TRYING TO EXPLAIN HOW IT IS USED, THEN GETTING GREAT FEEDBACK AND IT HAD BEEN USED WITH CENTRAL LINES AND THERE WAS NO ISSUE. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON (B)(6) 2025 FOR CARPUJECT HOLDER: THE COMPLAINT ABOUT THE USE OF THE HOLDER FOR AN UNKNOWN LOT CARPUJECT HOLDER. THE INVESTIGATION INCLUDED REVIEWING THE SUB-CLASS TRENDING FOR THE PRODUCT CONFIGURATION, PRODUCT INSERT INFORMATION AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO COMPLAINT SAMPLES OR PICTURES WERE PROVIDED. THE FINAL SCOPE WILL REMAIN AN UNKNOWN LOT CARPUJECT HOLDER. THE COMPLAINT IS NOT CONFIRMED. AS THERE WAS NO DEFECT OR FAILURE NO ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WAS PERFORMED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. AN ISSUE ESCALATION WAS NOT WARRANTED FOR THIS COMPLAINT. PER THE MDCP RECORD THE EVENT IS DEVICE REPORTABLE. NO OTHER REGULATORY NOTIFICATIONS, SQRT (SITE QUALITY REVIEW TEAM) OR AQRT (AREA QUALITY REVIEW TEAM) WERE PERFORMED FOR THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT INVESTIGATION. THE REPORTED DEFECT IS NOT REPRESENTATIVE OF THE QUALITY OF THE BATCH AND REMAINS ACCEPTABLE FOR FURTHER DISTRIBUTION. DEVICE ENGINEERING INVESTIGATION CONCLUSION: THIS INVESTIGATION IS BASED ON THE INFORMATION CAPTURED IN THE COMPLAINT DESCRIPTION AND ARGUS REPORT. THE COMPLAINT ISSUE, UNABLE/DIFFICULT TO USE, WAS REPORTED. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS. ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. FOLLOW-UP (29APR2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE [OFF LABEL USE OF DEVICE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A PHARMACIST FROM MEDICAL INFORMATION TEAM AND PRODUCT QUALITY GROUP. A PATIENT (AGE AND GENDER NOT PROVIDED) RECEIVED CARPUJECT HOLDER (CARPUJECT HOLDER). THE PATIENT'S RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE OF DEVICE (NON-SERIOUS), OUTCOME "UNKNOWN", DESCRIBED AS "UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE". THE REPORTER CONSIDERED "UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE" ASSOCIATED TO CARPUJECT HOLDER. CAUSALITY FOR "UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). ADDITIONAL INFORMATION: CALLER UNABLE TO BE TRANSFERRED TO SAFETY FOR REPORTING OF OFF-LABEL USE. HCP DID NOT PROVIDE WHAT PRODUCT OR NDC THAT HAD BEEN USED WITH THE CARPUJECT IN THIS MANNER. IT WAS REPORTED RECEIVING FEEDBACK FROM CLINICIANS THAT THEY WERE UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE. THEY WERE TELLING IT CREATED TOO MUCH PRESSURE AND WILL RUIN THE ACCESS. HCP STATED, THEY HAD NOT HAD ANY QUALITY ISSUES. THEY WERE TRYING TO EXPLAIN HOW IT IS USED, THEN GETTING GREAT FEEDBACK AND IT HAD BEEN USED WITH CENTRAL LINES AND THERE WAS NO ISSUE. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 29APR2025 FOR CARPUJECT HOLDER: THE COMPLAINT ABOUT THE USE OF THE HOLDER FOR AN UNKNOWN LOT CARPUJECT HOLDER. THE INVESTIGATION INCLUDED REVIEWING THE SUB-CLASS TRENDING FOR THE PRODUCT CONFIGURATION, PRODUCT INSERT INFORMATION AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO COMPLAINT SAMPLES OR PICTURES WERE PROVIDED. THE FINAL SCOPE WILL REMAIN AN UNKNOWN LOT CARPUJECT HOLDER. THE COMPLAINT IS NOT CONFIRMED. AS THERE WAS NO DEFECT OR FAILURE NO ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WAS PERFORMED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. AN ISSUE ESCALATION WAS NOT WARRANTED FOR THIS COMPLAINT. PER THE MDCP RECORD THE EVENT IS DEVICE REPORTABLE. NO OTHER REGULATORY NOTIFICATIONS, SQRT (SITE QUALITY REVIEW TEAM) OR AQRT (AREA QUALITY REVIEW TEAM) WERE PERFORMED FOR THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT INVESTIGATION. THE REPORTED DEFECT IS NOT REPRESENTATIVE OF THE QUALITY OF THE BATCH AND REMAINS ACCEPTABLE FOR FURTHER DISTRIBUTION. DEVICE ENGINEERING INVESTIGATION CONCLUSION: THIS INVESTIGATION IS BASED ON THE INFORMATION CAPTURED IN THE COMPLAINT DESCRIPTION AND ARGUS REPORT. THE COMPLAINT ISSUE, UNABLE/DIFFICULT TO USE, WAS REPORTED. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS. ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 06MAY2025 FOR CARPUJECT HOLDER: MDCP INVESTIGATION SUMMARY AND CONCLUSION: MANUFACTURING SITE INVESTIGATION: THE PURPOSE OF THIS INVESTIGATION IS TO INVESTIGATE A REPORT RECEIVED ASSOCIATED WITH AN UNKNOWN LOT OF A CARPUJECT HOLDER. CALLER STATES THEY'RE UNABLE TO USE THE CARPUJECT HOLDER TO ADMINISTER MEDICATIONS THROUGH A CENTRAL LINE. THE COMPLAINT IS NOT CONFIRMED. AS THERE IS NO DEFECT OR FAILURE BEING REPORTED, A ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WILL NOT BE PERFORMED SINCE THE END USER IS INQUIRING ABOUT THE USE OF THE HOLDER. INFORMATION REGARDING HOW TO USE THE CARPUJECT AND CARPUJECT HOLDERS CAN BE FOUND IN VARIOUS LOCATIONS: INSTRUCTIONS FOR USE OF CARPUJECTS WITH HOLDER ARE AVAILABLE AT PFIZERPRO.COM. A CARPUJECT TRAINING POSTER, BROCHURES, AND PRODUCT DEMONSTRATION VIDEO CAN BE FOUND AT "READYTOUSE.PFIZERPRO.COM." THE READY-TO-USE (RTU) DELIVERY SYSTEM LEARNING WEBSITE, "LEARNPFIZERRTU.COM," PROVIDES: OVERVIEW OF PFIZER HOSPITAL READY-TO-USE PRODUCTS (INCLUDING THE CARPUJECTS AND HOLDERS); VIDEOS DEMONSTRATING USE; INTERACTIVE KNOWLEDGE CHECKS TO REINFORCE LEARNINGS; LINKS TO TOOLS AND RESOURCES. NO COMPLAINT SAMPLES NOR PICTURES WERE RECEIVED OR REQUESTED TO ASSIST IN THE INVESTIGATION AS A MANUFACTURING DEFECT IS NOT BEING REPORTED. THE BATCH RECORD, LOT TRENDING, LOT INVESTIGATION QUERY, MANUFACTURE PROCESS TREND QUERY, AND APRR WERE NOT PERFORMED AS THERE IS NOT A MANUFACTURE DEFECT BEING REPORTED FOR THE PRODUCT AND A LOT NUMBER WAS NOT PROVIDED. COMPLAINT SUB-CLASS TRENDING WAS PERFORMED FOR ADVERSE EVENT MD/MDCP FOR THE CARPUJECT/CARPUJECT HOLDER PRODUCT WITH 2 INVESTIGATIONS BEING RETURNED FOR THE TWO-YEAR QUERY TIME FRAME. PER THE DEFINED CRITERIA NO TREND WAS IDENTIFIED THEREFORE, THIS EVENT WILL NOT BE ELEVATED TO COMPLAINT MANAGEMENT REVIEW BOARD (CMRB). THE FINAL SCOPE WILL BE LIMITED TO AN UNKNOWN LOT OF CARPUJECT HOLDER AS THERE IS NOT A REPORTED MANUFACTURE DEFECT BEING REPORTED FOR THE PRODUCT, INSTEAD THE END USER WAS INQUIRING ABOUT THE USE OF THE CARPUJECT HOLDER. NO FURTHER INVESTIGATION IS REQUIRED. CONCLUSION: THE COMPLAINT ABOUT THE USE OF THE HOLDER FOR AN UNKNOWN LOT CARPUJECT HOLDER. THE INVESTIGATION INCLUDED REVIEWING THE SUB-CLASS TRENDING FOR THE PRODUCT CONFIGURATION, PRODUCT INSERT INFORMATION AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. NO COMPLAINT SAMPLES OR PICTURES WERE PROVIDED. THE FINAL SCOPE WILL REMAIN AN UNKNOWN LOT CARPUJECT HOLDER. THE COMPLAINT IS NOT CONFIRMED. AS THERE WAS NO DEFECT OR FAILURE NO ROOT CAUSE INVESTIGATION OF THE MANUFACTURING PROCESS WAS PERFORMED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO IMPACT ON PRODUCT QUALITY, REGULATORY COMPLIANCE, VALIDATION, STABILITY, OR PATIENT SAFETY. AN ISSUE ESCALATION WAS NOT WARRANTED FOR THIS COMPLAINT. PER THE MDCP RECORD THE EVENT IS DEVICE REPORTABLE. NO OTHER REGULATORY NOTIFICATIONS, SQRT (SITE QUALITY REVIEW TEAM) OR AQRT (AREA QUALITY REVIEW TEAM) WERE PERFORMED FOR THE REPORTED COMPLAINT. NO CORRECTIVE OR PREVENTATIVE ACTIONS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT INVESTIGATION. THE REPORTED DEFECT IS NOT REPRESENTATIVE OF THE QUALITY OF THE BATCH AND REMAINS ACCEPTABLE FOR FURTHER DISTRIBUTION. DEVICE ENGINEERING INVESTIGATION: THIS INVESTIGATION IS BASED ON THE INFORMATION CAPTURED IN THE COMPLAINT DESCRIPTION AND ARGUS REPORT. THE COMPLAINT ISSUE, UNABLE/DIFFICULT TO USE, WAS REPORTED. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS. ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. FOLLOW-UP (29APR2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. FOLLOW-UP (06MAY2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS.