BD SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB

Additional Manufacturer Narrative

H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB CONTAINED FOREIGN MATTER. VERBATIM: THE CUSTOMER HAS FOUND BLACK MATTER IN ONE OF THE SYRINGES. 2 FLUSHES WERE FOUND WITH PARTICLES INSIDE THE FLUSH.

Additional Manufacturer Narrative

PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED BLACK MATTER WAS FOUND IN ONE OF THE SYRINGES. TO SUPPORT THE INVESTIGATION, OUR QUALITY TEAM RECEIVED TWO EMPTY SYRINGES WITHOUT FLOW WRAP PACKAGING OR TIP CAPS FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS, IMPERFECTIONS, OR FOREIGN MATTER WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 303191, LOT 5162275. THE REVIEW IDENTIFIED NO QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, INCLUDING ANALYSIS OF THE RETURNED SAMPLES, THE CUSTOMERS REPORTED CONDITION COULD NOT BE CONFIRMED.

Description of Event or Problem

NO ADVERSE EVENTS OR PATIENT INJURY.