BD POSIFLUSH

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 THE BD SYRINGE 10ML SHORT PR SALINE 10ML FILL STOPPER WAS JAMMED / INSECURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 306499 BATCH # 4177623 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WANTED TO FOLLOW UP AS WE HAD ANOTHER ISSUE WITH THE PLUNGER FOR A NORMAL SALINE FLUSH YESTERDAY. THE NURSE WAS TRYING TO WITHDRAWAL BLOOD FROM A CENTRAL LINE AND WHEN SHE WENT TO PULL BACK ON THE SYRINGE, THE PLUNGER POPPED RIGHT OUT OF THE SYRINGE. THE LOT # IS 4177623. I HAD HER PLACE AN RL AS WELL BUT THIS HAS NOW HAPPENED MULTIPLE TIMES. CUSTOMER RESPONSE ON (B)(6) 2025. NO PATIENT HARM, THOUGH THE PLUNGER COMING OUT INAPPROPRIATELY DOES INCREASE THIS MEDICALLY COMPLEX PATIENT TO A RISK FOR A CENTRAL LINE ASSOCIATED BLOODSTREAM INFECTION DUE TO EXPOSURE OF THE OPENED CENTRAL LINE TO THE AIR. THE PRODUCT WAS SAVED AND WAS GIVEN TO OUR MATERIALS MANAGEMENT DEPARTMENT ON TUESDAY 9/9.

Additional Manufacturer Narrative

(B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT THE PLUNGER DISLODGED FROM THE SYRINGE WHEN THE USER ATTEMPTED TO PULL IT BACK. TO SUPPORT THE INVESTIGATION, ONE EMPTY SAMPLE¿WITHOUT PACKAGING OR FLOW WRAP¿WAS SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED, AND NO DEFECTS OR ABNORMALITIES WERE OBSERVED. IT IS POSSIBLE THAT THE PRODUCT WAS NOT USED AS INTENDED. THE FLUSH SYRINGE IS DESIGNED FOR SINGLE-USE APPLICATION, SPECIFICALLY TO DEPRESS THE PLUNGER ROD TO EXPEL THE SOLUTION. IT IS NOT INTENDED FOR ASPIRATION OR FOR DRAWING BLOOD BY PULLING BACK ON THE PLUNGER. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306499, LOT 4177623. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE IN COMPLIANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE SUBMITTED SAMPLE, THE REPORTED ISSUE COULD NOT BE CONFIRMED.