BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD - ALLAN FRENCH EYE NEEDLE

    MDR report key: 8640693 · Received May 23, 2019

    Report

    Report Number
    MW5086893
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Manufacturer
    ASPEN SURGICAL PRODUCTS INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEEDLE USED DURING ORTHOPEDIC SURGERY. TIP BROKE OFF INTO BONE. SURGEON USED PRODUCT DURING ORTHOPEDIC SURGERY. BIT BROKE OFF IN BONE, TECH NOTICED IT. SURGEON WAS THEN NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428246 RICHARD - ALLAN FRENCH EYE NEEDLE NEEDLE, HYPODERMIC SINGLE LUMEN FMI ASPEN SURGICAL PRODUCTS INC. 145457

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO