BD PUREHUB¿ DISINFECTING CAP

Additional Manufacturer Narrative

UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLE, BATCH, OR LOT CODE WAS PROVIDED. THIS COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED & TRENDED FOR FUTURE OCCURRENCES. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT A HEPARIN FLUSH COULD NOT BE COMPLETED ON THE UNSPECIFIED BD¿ IV CATHETER PICC LINE DURING USE, AND COULDN'T BE PULLED BACK TO OBTAIN BLOOD RETURN. USING A SECOND SYRINGE CAUSED THE FLUSH TO BE COMPLETED SUCCESSFULLY, BUT A "SMALL BLUE FRAGMENT" WAS NOTICED INSIDE THE CATHETER'S LUMEN. THE SPOUSE HAD CLEANED THE END OF THE INJECTION CAP WITH AN "ALCOHOL PREP PAD" PRIOR TO ATTEMPTING THE FLUSH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE ATTEMPTED TO FLUSH LUMEN OF PICC LINE WITH HEPARIN FLUSH AND LINE WOULD NOT FLUSH. SHE TRIED TO PULL BACK TO OBTAIN BLOOD RETURN AND WAS ABLE TO DO SO. SHE THEN GOT A SECOND SYRINGE OF HEPARIN AND ATTEMPTED TO FLUSH AGAIN. THIS TIME, SHE WAS ABLE TO DO SO; HOWEVER, NOTICED A SMALL BLUE FRAGMENT PIECE INSIDE THE LUMEN OF THE CATHETER. SHE IMMEDIATELY STOPPED, PLACED A NEW PUREHUB CAP ON THE LINE AND CALLED PHIT." "PHIT RN, JP, VISITED THE PATIENT. PICTURES TAKEN OF FRAGMENT INSIDE CATHETER. SHE WAS ABLE TO PULL BACK FRAGMENT INSIDE SYRINGE. RYMED CAP CHANGED, LINE FLUSHED, NEW PUREHUB CAP PLACED. RN THEN NOTIFIED QUALITY MANAGER. THE SYRINGE USED TO PULL BACK THE FRAGMENT HAS ALREADY BEEN PLACED IN THE SHARPS CONTAINER IN THE PATIENTS HOME. " "QUALITY MANAGER CALLED SPOUSE TO OBTAIN MORE DETAILS OF THE INCIDENT. SPOUSE DOES REMEMBER CLEANING END OF INJECTION CAP WITH ALCOHOL PREP PAD PRIOR TO ATTEMPTING TO FLUSH WITH HEPARIN; HOWEVER, UNCLEAR IF SHE VISUALLY INSPECTED THE TIP OF THE INJECTION CAP AS IT APPEARS THE SPONGE IS STUCK TO THE END OF THE INJECTION CAP PER THE PICTURES."

Description of Event or Problem

IT WAS REPORTED THAT A HEPARIN FLUSH COULD NOT BE COMPLETED ON THE IV CATHETERS PICC LINE DURING USE, AND COULDN'T BE PULLED BACK TO OBTAIN BLOOD RETURN. USING A SECOND SYRINGE CAUSED THE FLUSH TO BE COMPLETED SUCCESSFULLY, BUT A "SMALL BLUE FRAGMENT" WAS NOTICED INSIDE THE CATHETER'S LUMEN, WHICH CAME OFF OF THE BD PUREHUB¿ DISINFECTING CAP. THE SPOUSE HAD CLEANED THE END OF THE INJECTION CAP WITH AN "ALCOHOL PREP PAD" PRIOR TO ATTEMPTING THE FLUSH, AND AFTER NOTICING THE FOREIGN PARTICLE, REPLACED THE CAP. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE ATTEMPTED TO FLUSH LUMEN OF PICC LINE WITH HEPARIN FLUSH AND LINE WOULD NOT FLUSH. SHE TRIED TO PULL BACK TO OBTAIN BLOOD RETURN AND WAS ABLE TO DO SO. SHE THEN GOT A SECOND SYRINGE OF HEPARIN AND ATTEMPTED TO FLUSH AGAIN. THIS TIME, SHE WAS ABLE TO DO SO; HOWEVER, NOTICED A SMALL BLUE FRAGMENT PIECE INSIDE THE LUMEN OF THE CATHETER. SHE IMMEDIATELY STOPPED, PLACED A NEW PUREHUB CAP ON THE LINE AND CALLED PHIT." "PHIT RN, JP, VISITED THE PATIENT. PICTURES TAKEN OF FRAGMENT INSIDE CATHETER. SHE WAS ABLE TO PULL BACK FRAGMENT INSIDE SYRINGE. RYMED CAP CHANGED, LINE FLUSHED, NEW PUREHUB CAP PLACED. RN THEN NOTIFIED QUALITY MANAGER. THE SYRINGE USED TO PULL BACK THE FRAGMENT HAS ALREADY BEEN PLACED IN THE SHARPS CONTAINER IN THE PATIENTS HOME. " "QUALITY MANAGER CALLED SPOUSE TO OBTAIN MORE DETAILS OF THE INCIDENT. SPOUSE DOES REMEMBER CLEANING END OF INJECTION CAP WITH ALCOHOL PREP PAD PRIOR TO ATTEMPTING TO FLUSH WITH HEPARIN; HOWEVER, UNCLEAR IF SHE VISUALLY INSPECTED THE TIP OF THE INJECTION CAP AS IT APPEARS THE SPONGE IS STUCK TO THE END OF THE INJECTION CAP PER THE PICTURES."

Additional Manufacturer Narrative

CORRECTION: THE CATALOG NUMBER HAS BEEN PROVIDED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A HEPARIN FLUSH COULD NOT BE COMPLETED ON THE IV CATHETERS PICC LINE DURING USE, AND COULDN'T BE PULLED BACK TO OBTAIN BLOOD RETURN. USING A SECOND SYRINGE CAUSED THE FLUSH TO BE COMPLETED SUCCESSFULLY, BUT A "SMALL BLUE FRAGMENT" WAS NOTICED INSIDE THE CATHETER'S LUMEN, WHICH CAME OFF OF THE BD PUREHUB¿ DISINFECTING CAP. THE SPOUSE HAD CLEANED THE END OF THE INJECTION CAP WITH AN "ALCOHOL PREP PAD" PRIOR TO ATTEMPTING THE FLUSH, AND AFTER NOTICING THE FOREIGN PARTICLE, REPLACED THE CAP.. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE ATTEMPTED TO FLUSH LUMEN OF PICC LINE WITH HEPARIN FLUSH AND LINE WOULD NOT FLUSH. SHE TRIED TO PULL BACK TO OBTAIN BLOOD RETURN AND WAS ABLE TO DO SO. SHE THEN GOT A SECOND SYRINGE OF HEPARIN AND ATTEMPTED TO FLUSH AGAIN. THIS TIME, SHE WAS ABLE TO DO SO; HOWEVER, NOTICED A SMALL BLUE FRAGMENT PIECE INSIDE THE LUMEN OF THE CATHETER. SHE IMMEDIATELY STOPPED, PLACED A NEW PUREHUB CAP ON THE LINE AND CALLED PHIT." "PHIT RN, JP, VISITED THE PATIENT. PICTURES TAKEN OF FRAGMENT INSIDE CATHETER. SHE WAS ABLE TO PULL BACK FRAGMENT INSIDE SYRINGE. RYMED CAP CHANGED, LINE FLUSHED, NEW PUREHUB CAP PLACED. RN THEN NOTIFIED QUALITY MANAGER. THE SYRINGE USED TO PULL BACK THE FRAGMENT HAS ALREADY BEEN PLACED IN THE SHARPS CONTAINER IN THE PATIENTS HOME." "QUALITY MANAGER CALLED SPOUSE TO OBTAIN MORE DETAILS OF THE INCIDENT. SPOUSE DOES REMEMBER CLEANING END OF INJECTION CAP WITH ALCOHOL PREP PAD PRIOR TO ATTEMPTING TO FLUSH WITH HEPARIN; HOWEVER, UNCLEAR IF SHE VISUALLY INSPECTED THE TIP OF THE INJECTION CAP AS IT APPEARS THE SPONGE IS STUCK TO THE END OF THE INJECTION CAP PER THE PICTURES." D.1. MEDICAL DEVICE BRAND NAME: BD PUREHUB¿ DISINFECTING CAP. D.2. COMMON DEVICE NAME: DEVICE DISINFECTANT ALCOHOL PAD. D.2. MEDICAL DEVICE TYPE: LKB. D.2. MEDICAL DEVICE CATALOG#: 306596. D.3. MEDICAL DEVICE MANUFACTURER: BD MEDICAL (BD WEST) MEDICAL SURGICAL. D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2. MANUFACTURING LOCATION: BD MEDICAL (BD WEST) MEDICAL SURGICAL. G.5. PMA / 510(K)#: EXEMPT H3 OTHER TEXT : SEE SECTION H.10.