BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH

    MDR report key: 3833666 · Received May 21, 2014

    Report

    Report Number
    MW5036217
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BD
    Product Code
    NGT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE OVERWRAP FROM A PREFILLED BD SYRINGE OF A 0.9% NAC1 IS TORN THEREFORE EXPOSING SYRINGE. THE PRODUCT NOW IS NOT TAMPER PROOF. AMOUNT: 0.9% NAC1 SYRINGE, FREQUENCY: PRN/AS NEEDED, ROUTE: INTRAVENOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301477 BD POSIFLUSH 0.9% NACL PREFILLED 10ML SYRINGE NGT BD 4041170

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA