BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECTON DICKINSON & CO

    MDR report key: 512948 · Received February 13, 2004

    Report

    Report Number
    MW1031184
    Event Type
    Malfunction
    Date Received
    February 13, 2004
    Date of Event
    February 12, 2004
    Report Date
    February 13, 2004
    Manufacturer
    BECTON DICKINSON & CO
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PRODUCT DEFECT ON 20 G 1 INCH BD NEEDLE. THE SEAL/GLUE THAT HOLDS THE NEEDLE INTO THE HUB FLAKES OFF AND SOMETIMES STICKS TO THE BEVEL WHICH COULD LEAD TO POTENTIAL CONTAMINATION OF IV PRODUCT AND COULD BE INCORPORATED INTO FINAL IV PRODUCT THAT THE PT RECEIVES. THIS IS EXTREMELY UNSAFE FOR PTS RECEIVING INTRATHECAL MEDICATIONS AS WELL AS OTHER IV MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECTON DICKINSON & CO PRECISION GLIDE NEEDLE 20 G 1 INCH FMI BECTON DICKINSON & CO * 3091363 08

    Patients

    Seq Age Sex Outcome Treatment
    1 *