BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXA TWO-FER-TM- 16 GAUGE NEEDLES

    MDR report key: 1288085 · Received January 13, 2009

    Report

    Report Number
    MW5009604
    Event Type
    Malfunction
    Date Received
    January 13, 2009
    Date of Event
    January 13, 2009
    Report Date
    January 13, 2009
    Manufacturer
    BAXA CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DURING DRUG PREPARATION USING BAXA TWO-FER-TM- 16 GAUGE NEEDLES, THE NEEDLE HAS BEEN NOTED TO DETACH FROM THE HUB, LEADING TO DRUG SPILLAGE AND CREATING A HAZARDOUS CONDITION FOR STAFF PREPARING MEDICATION. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: USED FOR INTRAVENOUS MEDICATION PREPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXA TWO-FER-TM- 16 GAUGE NEEDLES NONE FMI BAXA CORPORATION ORDER NO. REF: 719362

    Patients

    Seq Age Sex Outcome Treatment
    1