BD POSIFLUSH

Description of Event or Problem

NO HARM HAS COME TO THE PATIENT.

Additional Manufacturer Narrative

(B)(4). FOLLOW UP FOR DEVICE EVALUATION. A BLACK PARTICULATE RESEMBLING AN INSECT WAS REPORTEDLY OBSERVED FLOATING IN THE SYRINGE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE WITHOUT FLOW WRAP PACKAGING WAS RECEIVED FOR EVALUATION BY THE QUALITY TEAM. THE SYRINGE CONTAINED 3.5ML OF SOLUTION, AND THE PLUNGERS RUBBER STOPPER WAS POSITIONED AT THE 8ML GRADUATION MARK. A VISUAL INSPECTION IDENTIFIED NO FOREIGN MATTER. THE SOLUTION WAS SUBSEQUENTLY TRANSFERRED TO A GLASS CONTAINER, WHERE NO FOREIGN MATTER WAS OBSERVED UPON RE INSPECTION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306547, LOT 5212358. THE REVIEW REVEALED NO DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT 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 THE ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMERS REPORTED CONDITION COULD NOT BE CONFIRMED.

Description of Event or Problem

IT WAS REPORTED THAT BD SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL CONTAINED FOREIGN MATTER. VERBATIM: PATIENT STATES THERE IS SOMETHING BLACK FLOATING IN THE SYRINGE THAT LOOKS LIKE A BUG.

Additional Manufacturer Narrative

H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.