BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGEL WING 23G BCS W/LUER ADPTR

    MDR report key: 3063935 · Received April 4, 2013

    Report

    Report Number
    1282497-2013-00008
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Report Date
    March 8, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A BLOOD COLLECTION DEVICE. THE CUSTOMER REPORTS THE METAL NEEDLE GUARD POPPED OFF WHEN THE CLINICIAN MOVED THE GUARD UP TO CAP AT THE END OF THE NEEDLE AFTER THE CLINICIAN DREW BLOOD. THE CUSTOMER ALSO STATED THAT THERE WAS NO MEDICAL INTERVENTION NEEDED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139706 ANGEL WING 23G BCS W/LUER ADPTR BLOOD COLLECTION DEVICE GJE COVIDIEN 8881225307 122920027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK