BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 21692647 · Received March 25, 2025

    Report

    Report Number
    1911916-2025-00230
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    March 14, 2025
    Report Date
    March 18, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    MATERIAL #305180. LOT #4212685. VERBATIM: WHEN USING THE BLUNT NEEDLE FENTANYL, CORING WAS OBSERVED IN SYRINGE (SEE PICTURE ATTACHED) BEFORE ADMINISTERING TO PATIENT. -CUSTOMER RESPONSE RECEIVED: WHAT IS THE BRAND OF MEDICATION BEING USED WHEN CORING IS OCCURRING? MULTIPLE BRANDS OF MEDICATION IS THE SAME NEEDLE BEING USED TO PUNCTURE MULTIPLE VIALS? NO. WHAT ANGLE IS THE NEEDLE ENTERING THE VIAL AT: 90-DEGREE OR 45-DEGREE ANGLE? UNSURE OF ANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718452 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4212685 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown