SYRINGE 5ML HEPARIN 10 UNIT

Additional Manufacturer Narrative

(B)(6). FOLLOW UP: IT WAS REPORTED A SYRINGE WAS NOTED TO HAVE AIR IN THE SYRINGE AND NO FLUID. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306414 AND LOT NUMBER 429953N. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

Description of Event or Problem

MATERIAL #306414. BATCH #429953N. IT WAS REPORTED BY THE CUSTOMER THAT A SYRINGE WAS NOTED TO HAVE AIR IN THE SYRINGE AND NO FLUID/HEPARIN. THE USER NOTED THE ABSENCE OF FLUID UPON OPENING AND PRIMING FOR INSTALLATION INTO AN ARTERIAL LINE IN THE NICU. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REPORTING AN ADDITIONAL SAFETY EVENT WITH THE BD POSIFLUSH PREFILLED HEPARIN LOCK FLUSH SYRINGE, 5 ML SYRINGE 5 ML HEPARIN FILL, 10 USP UNITS/ML, SKU 306414. A SYRINGE WAS NOTED TO HAVE AIR IN THE SYRINGE AND NO FLUID/HEPARIN. THE USER NOTED THE ABSENCE OF FLUID UPON OPENING AND PRIMING FOR INSTALLATION INTO AN ARTERIAL LINE IN THE NICU. ITEM SAVED AND AVAILABLE FOR RETURN. LOT NUMBER 429953N, EXPIRATION DATE OF 04/30/2026. IT IS THE SAME LOT NUMBER AS THE PREVIOUS REPORT FROM 1/13/25, BD REFERENCE NUMBER (B)(4). ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO, CAUGHT BY USER JUST PRIOR TO ADMINISTRATION TO PATIENT. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2025. 3. TOTAL NUMBER OF OCCURRENCES? ONE EVENT ON THAT DATE, THREE EVENTS TOTAL. 4. COULD YOU PLEASE RE CONFIRM THE FACILITY ADDRESS. ADDITIONAL INFO: WE DID HAVE THE SAME ISSUE TWICE IN THAT WEEK WITH THE SAME LOT NUMBER. EVENT DATES (B)(6) 2025. BOTH AVAILABLE FOR RETURN.

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.