BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDER NEEDLE 45 DEG LEFT

    MDR report key: 10777402 · Received November 3, 2020

    Report

    Report Number
    8043971-2020-01420
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    February 13, 2020
    Report Date
    February 13, 2020
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    MBI
    UDI-DI
    10810190015527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIDES OF THE SECTION AS SEEN IN THE PICTURE OF THE DEVICE ARE EVEN AND MEET THE ENGINEERING REQUIREMENTS. THE DEVICE WAS WRONG USE (SEE REMARK MARKED ABOVE WITH AN ARROW) CAUSING THE DEVICE FAILURE

    Description of Event or Problem · 1

    SLIDER NEEDLE SNAPPED AT DISTAL TIP IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247674 SLIDER NEEDLE 45 DEG LEFT SLIDER NEEDLE 45 DEG LEFT MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD 3910-500-752 10810190015527

    Patients

    Seq Age Sex Outcome Treatment
    1