BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN SAFETY NEEDLE 25X5/8 INTL

    MDR report key: 956724 · Received December 3, 2007

    Report

    Report Number
    1017768-2007-00024
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    November 20, 2007
    Report Date
    November 22, 2007
    Manufacturer
    TYCO/KENDALL HEALTHCARE
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    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 TYCO/KENDALL HEALTHCARE THAT A CUSTOMER HAD A PROBLEM WITH THE MAGELLAN SAFETY SYRINGE. THE CUSTOMER REPORTS SDMH F3 MATERNITY - ADMINISTERING VIT K TO A PATIENT (BABY) WHEN NEEDLE DETACHED ITSELF FROM THE HILT. NEEDLE REMAINED IN BABY'S THIGH - SUFFICIENT NEEDLE LENGTH OUTSIDE OF THE BABY TO ALLOW FOR GENTLE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGELLAN SAFETY NEEDLE 25X5/8 INTL SAFETY NEEDLE FMI TYCO/KENDALL HEALTHCARE 5551850558 401510

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOW YR