BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN BC 21G X 1.25"

    MDR report key: 2123632 · Received June 10, 2011

    Report

    Report Number
    1650158-2011-00005
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A BLOOD COLLECTION DEVICE. THE CUSTOMER REPORTS THE BLOOD COLLECTION NEEDLE CAME DETACHED FROM THE BLOOD TUBE HOLDER. THE PHLEBOTOMIST INSERTED THE NEEDLE/DEVICE INTO THE PT. WHEN SHE WENT TO TAKE IT OUT OF THE PT'S ARM, THE NEEDLE REMAINED IN THE PT'S ARM. THE NEEDLE WAS THEN REMOVED FROM THE PT WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGELLAN BC 21G X 1.25" BLOOD COLLECTION DEVICE FMI COVIDIEN 8881227121 108000328

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK