BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGEL WING 23G BCS W/LUER ADPTR

    MDR report key: 1419677 · Received April 15, 2009

    Report

    Report Number
    1282497-2009-00016
    Event Type
    Malfunction
    Date Received
    April 15, 2009
    Report Date
    April 2, 2009
    Manufacturer
    COVIDIEN
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). A INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 04/02/2009 THAT A CUSTOMER HAD AN ISSUE WITH A BLOOD COLLECTION NEEDLE. CUSTOMER REPORTS THAT THEY RECEIVED ONE PACKAGE THAT CONTAINED TWO ANGLE WING DEVICES. ONE OF THE DEVICES APPEARED DAMAGED AND THE NEEDLE HAD BEEN BROKEN IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGEL WING 23G BCS W/LUER ADPTR BLOOD COLLECTION NEEDLE GJE COVIDIEN 8881225307 8165232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA