BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT

    MDR report key: 4956411 · Received July 27, 2015

    Report

    Report Number
    MW5044944
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 27, 2015
    Manufacturer
    INTEGRA LIFE SCIENCES
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MD WAS USING A 6 INCH NEEDLE HOLDER AND TIP BROKE OFF. MD RETRIEVED ENTIRE BROKEN PIECE AND 2 STAFF RNS VERIFIED BROKEN PIECE MATCHED NEEDLE HOLDER. NO X-RAY NEEDED. NO INJURY TO PATIENT. NEEDLE HOLDER AND TIP SEND TO RISK MANAGEMENT FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487115 JARIT NEEDLE HOLDER FHQ INTEGRA LIFE SCIENCES 123-135

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR