BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SYRINGE

    MDR report key: 3877427 · Received June 12, 2014

    Report

    Report Number
    MW5036635
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 11, 2014
    Manufacturer
    EXELING
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS EXELINT INTERNATIONAL CO. BRAND DISPOSABLE SYRINGES WITH NEEDLES 3ML 25G 1: REF#26111, LOT #130404 WITH EXPIRATION 03/01/2018 DEFECTIVE. PATIENT DESCRIBED AFTER ENSURING NEEDLE CORRECTLY ATTACHED TO SYRINGE BODY, NEEDLE SEPARATED FROM SYRINGE WHILE PRESSURE APPLIED TO PLUNGER (NEEDLE POPPED OUT). PATIENT INDICATES THAT NOT ALL IN THE PACKAGE HAD THE SAME PROBLEM. DO NOT HAVE SPECIFICS. ONLY SYRINGE/NEEDLE COMBINATION PROBLEM, PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347779 DISPOSABLE SYRINGE DISPOSABLE SYRINGE FMF EXELING 26111 130404

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR