BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD-ALLAN NEEDLE 1/2 CIRCLE TAPER

    MDR report key: 17245826 · Received July 3, 2023

    Report

    Report Number
    17245826
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    February 16, 2023
    Report Date
    June 22, 2023
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INSTRUMENT MALFUNCTION RICHARD-ALLAN NEEDLES 0.5" BROKE DURING USE. SMALL PIECE OF NEEDLED DROPPED ON THE GROUND DURING SURGERY. MISSING PIECE WAS FOUND ON GROUND. NO OTHER MISSING PIECES NOTED. THIS IS THE 3RD TIME THIS WEEK WHERE THIS BRAND OF NEEDLE BROKE. REF# 216706, LOT# 211886, EXP [REDACTED DATE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252794 RICHARD-ALLAN NEEDLE 1/2 CIRCLE TAPER NEEDLE, SUTURING, DISPOSABLE GAB ASPEN SURGICAL PRODUCTS, INC. 216706 211886

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown