BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN BC 21G X 1.25"

    MDR report key: 2910676 · Received December 4, 2012

    Report

    Report Number
    1650158-2012-00015
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Report Date
    November 15, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A MAGELLAN BLOOD COLLECTION DEVICE. THE CUSTOMER REPORTS THAT THE NEEDLE DETACHED IN THE PATIENT'S ARM. THE TECHNICIAN THEN REMOVED THE NEEDLE WITH THEIR FINGERS, NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGELLAN BC 21G X 1.25" MAGELLAN BLOOD COLLECTOR FMI COVIDIEN 8881227121 129200128

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK