BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 21684632 · Received March 24, 2025

    Report

    Report Number
    1911916-2025-00221
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    March 11, 2025
    Report Date
    March 25, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THERE IS A WHITE SUBSTANCE ON THE BOTTOM NEAR THE HUB. TO AID IN THE INVESTIGATION, ONE SAMPLE WAS RECEIVED IN AN OPENED PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED, AND THE NEEDLE HUB HAS AN EPOXY DRIP OVER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION OCCURS DURING THE ASSEMBLY PROCESS IF THERE IS A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305180, LOT 4212669. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    MATERIALS: 305180 BATCH#: 4305302, 4212669. VERBATIM: CONTAMINATED BLUNT FILL NEEDLE WITH WHITE SUBSTANCE ON THE BOTTOM NEAR THE HUB. RESPONSE ON (B)(6)2025, WE ACTUALLY FOUND ANOTHER ONE OF A DIFFERENT LOT NUMBER WHILE WE WERE INVESTIGATING. THAT LOT IS 4212669. IT APPEARS TO POSSIBLY BE THE ADHESIVE OR WHITE PART THAT MAKES THE NEEDLE STICK INTO THE HUB THAT POSSIBLY DRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131897 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4212669 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown