BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGEL WING 23G BCS W/ LUER ADPTR

    MDR report key: 4120816 · Received July 28, 2014

    Report

    Report Number
    1282497-2014-00044
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A BLOOD COLLECTION SET. THE CUSTOMER REPORTS THE SAFETY COVER DID NOT ACTIVATE AS EXPECTED. WHEN PULLING BACK THE WINGS THE COVER DOES NOT ACTIVATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440018 ANGEL WING 23G BCS W/ LUER ADPTR BLOOD COLLECTION SET GJE COVIDIEN 8881225307 140450242X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK