BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN SAFE BC HLDR 1.25X21G

    MDR report key: 1182018 · Received September 26, 2008

    Report

    Report Number
    1650158-2008-00008
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 15, 2008
    Manufacturer
    COVIDIEN
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 THAT A CUSTOMER HAD A PROBLEM WITH A BLOOD COLLECTION HOLDER. THE CUSTOMER REPORTS WHILE DRAWING BLOOD FROM A PATIENT, HE WASN'T GETTING ANY BLOOD RETURN INTO THE TUBE. CUSTOMER STATED WHEN HE PROCEEDED TO PULL THE NEEDLE OUT OF THE PATIENT'S ARM TO CHECK ON PUNCTURE SITE, THE NEEDLE STAYED IN THE PATIENT'S ARM AND HE WAS LEFT HOLDING THE TUBE HOLDER IN HIS HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGELLAN SAFE BC HLDR 1.25X21G BLOOD COLLECTION HOLDER JKA COVIDIEN 8881226121 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK