BD SYRINGE NRFIT¿ LOK

Additional Manufacturer Narrative

B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO SAMPLE OR PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT POTENTIAL ROOT CAUSE FOR THE MIXED PRODUCT DEFECT IS ASSOCIATED WITH INADEQUATE LINE CLEARANCE ON THE MARKING MACHINERY AND FAILURE TO FOLLOW PROPER PROCEDURES FOR GOODS ISSUING. A CORRECTIVE ACTION PROJECT WAS OPENED TO FURTHER INVESTIGATE THIS DEFECT. A QUALITY ALERT WAS ISSUED TO THE SITE AND ASSOCIATES INVOLVED IN BATCH MANUFACTURING WERE RE-TRAINED TO PROPER MANUFACTURING PRACTICES AROUND LINE CLEARANCES, GOODS ISSUES, AND MATERIAL HANDLING. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1041220. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE BD SYRINGE NRFIT¿ LOK HAD MIXED PRODUCT / LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TIP OF THE NR FIT SYRINGE WAS OF A DIFFERENT DESIGN SO DIDN'T FIT THE DESIGNATED NEEDLES IT WAS DESIGNED FOR. ADDITIONAL INFORMATION PROVIDED: NO PATIENT WAS HARMED IN THE EVENT. I¿M NOT SURE OF THE EXACT DATE BUT IT WAS OCTOBER 2024. WE HAVE SEVERAL UNUSED SAMPLES AVAILABLE FOR COLLECTION.

Additional Manufacturer Narrative

(B)(6) - SUPPLEMENTAL MDR - MIXED PRODUCT / LOTS. NO SAMPLE OR PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT POTENTIAL ROOT CAUSE FOR THE MIXED PRODUCT DEFECT IS ASSOCIATED WITH INADEQUATE LINE CLEARANCE ON THE MARKING MACHINERY AND FAILURE TO FOLLOW PROPER PROCEDURES FOR GOODS ISSUING. A CORRECTIVE ACTION PROJECT WAS OPENED TO FURTHER INVESTIGATE THIS DEFECT. A QUALITY ALERT WAS ISSUED TO THE SITE AND ASSOCIATES INVOLVED IN BATCH MANUFACTURING WERE RE-TRAINED TO PROPER MANUFACTURING PRACTICES AROUND LINE CLEARANCES, GOODS ISSUES, AND MATERIAL HANDLING. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1041220. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

Description of Event or Problem

NO ADDITIONAL INFORMATION WAS PROVIDED.