BD SYRINGE 5ML HEPARIN 10 UNIT

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE HEPARIN FLUSH WAS FOUND EMPTY PRIOR TO USE. BECAUSE A PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, ONE PHOTOGRAPH WAS PROVIDED FOR REVIEW BY THE QUALITY TEAM. THE IMAGE SHOWS A PREFILLED SYRINGE POSITIONED VERTICALLY AND UPSIDE DOWN, WITHOUT ITS PACKAGING FLOW WRAP, AND APPEARING TO CONTAIN NO SOLUTION. NO ADDITIONAL DETAILS COULD BE OBTAINED FROM THE PHOTOGRAPH. THIS CONDITION MAY OCCUR IF A JAM OCCURS DURING THE FILLING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 306414, LOT 434189N. THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL PROCESSES AND FINAL INSPECTIONS WERE COMPLETED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. ADDITIONAL CONTROLS HAVE BEEN IMPLEMENTED IN THE FILLING PROCESS TO PREVENT SIMILAR OCCURRENCES. BASED ON THE INVESTIGATION AND THE PHOTOGRAPHIC EVIDENCE, THE CUSTOMER¿S REPORTED OBSERVATION HAS BEEN CONFIRMED. 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 5ML HEPARIN 10 UNIT WAS EMPTY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEPARIN SYRINGE EMPTY BEFORE USE.

Additional Manufacturer Narrative

(B)(4). FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THAT THE HEPARIN FLUSH WAS FOUND EMPTY PRIOR TO USE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE LACKING FLOW-WRAP PACKAGING AND ONE PHOTOGRAPH WERE PROVIDED TO THE QUALITY TEAM FOR REVIEW. UPON VISUAL INSPECTION, THE SYRINGE WAS FOUND TO BE EMPTY, WITH NO SOLUTION PRESENT. THE IMAGE SHOWS A PREFILLED SYRINGE POSITIONED VERTICALLY AND UPSIDE DOWN, WITHOUT ITS PACKAGING FLOW WRAP, AND APPEARING TO CONTAIN NO SOLUTION. NO ADDITIONAL DETAILS COULD BE OBTAINED FROM THE PHOTOGRAPH. THIS CONDITION MAY OCCUR IF A JAM OCCURS DURING THE FILLING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 306414, LOT 434189N. THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL PROCESSES AND FINAL INSPECTIONS WERE COMPLETED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. ADDITIONAL CONTROLS HAVE BEEN IMPLEMENTED IN THE FILLING PROCESS TO PREVENT SIMILAR OCCURRENCES. BASED ON THE INVESTIGATION AND THE RETURNED SAMPLE ANALYSIS, THE CUSTOMER¿S REPORTED OBSERVATION HAS BEEN CONFIRMED.