BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD-ALLAN NEEDLE 1/2 CIRCLE TAPER

    MDR report key: 20461126 · Received October 16, 2024

    Report

    Report Number
    20461126
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    July 8, 2024
    Report Date
    July 9, 2024
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    USING FREE NEEDLE AND EYELET OF NEEDLE BROKE OFF. UNABLE TO FIND PIECE SO X-RAY DONE. PIECE WAS NOT FOUND ON X-RAY. FREE NEEDLE INFORMATION REF 216706 STYLE MAYO 1/2 TAPER LOT NUMBER: 369324 ASPEN SURGICAL EXPIRATION DATE 2029-01-01, (B)(4) ASSISTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425217 RICHARD-ALLAN NEEDLE 1/2 CIRCLE TAPER NEEDLE, SUTURING, DISPOSABLE GAB ASPEN SURGICAL PRODUCTS, INC. 216706 369324

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female