BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL W/NDL 21GX1IN

    MDR report key: 21076435 · Received January 5, 2025

    Report

    Report Number
    9614033-2024-00091
    Event Type
    Malfunction
    Date Received
    January 5, 2025
    Date of Event
    December 3, 2024
    Report Date
    February 20, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903096428
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: TWO PHOTOS AND SIX 10ML SYRINGES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE PHOTOS SHOW RED LIQUID LEAKING PAST THE STOPPER. DURING VISUAL INSPECTION OF THE SIX PHYSICAL SAMPLES, IT WAS OBSERVED THAT THE BARREL OF THE SYRINGE WAS DENTED. THIS DAMAGE COULD CAUSE LEAKAGE. THE SAMPLES WERE THEN SENT FOR TESTING. ALL SIX OF THE DAMAGED SYRINGES SHOWED LEAKAGE. THE REPORTED INCIDENT COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE CAN BE LINKED TO PRODUCTION. ACTIONS HAVE BEEN PUT IN PLACE; HOWEVER, THE REPORTED LOT NUMBER WAS MANUFACTURED PRIOR TO THESE ACTIONS BEING PUT INTO PLACE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Description of Event or Problem · 0

    MATERIAL: 30964220. LOT: 3264115. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21GX1IN BARREL FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY A CLINICAL MANAGER VIA EMAIL THAT ON (B)(6)2024. THE SYRINGE IS LEAKING FROM THE STOPPER SIDE, AND THERE ARE NOTICEABLE DENTS AND IRREGULARITIES IN ITS SHAPE. COMPLAINT#: (B)(4). PRODUCT: BD 10ML LUER-LOK SYRINGE 21GX1IN_3096422. PRODUCT #: 15-6422-0. LOT NUMBER#: 3264115. ADDITIONAL INFORMATION PROVIDED: 1) CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 2/12/2024, 03/12/22024, 04/12/2024. 2) WHAT WAS THE IMPACT TO THE PATIENT? ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADVERSE EVENT, MEDICATION OVERSPILL AND BLOOD LEAK BUT DETECTED AND RESOLVED BEFORE TURNING INTO ADVERSE EVENT. 3) ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? SAMPLE AVAILABLE. CLINIC ADDRESS - (B)(6).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136545 BD SYRINGE 10ML LL W/NDL 21GX1IN PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 3264115 00382903096428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown