BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER

    MDR report key: 10521351 · Received September 11, 2020

    Report

    Report Number
    3014527682-2020-00013
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Report Date
    September 11, 2020
    Manufacturer
    ASPEN SURGICAL
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DISCOVERED DURING PROCEDURE, NO DELAY TO CASE, NO HARM TO PATIENT, BUT THERE WAS PATIENT CONTACT. BLADES WERE DULL IN CUSTOM PACKS. THE DULL BLADES WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PACK 880151009 (SURGI START) LOT NUMBERS 2003543811 AND 2002944022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990305 BARD-PARKER BLADE SURG RIB BCK BARB 10 GES ASPEN SURGICAL 371110 0209336 AND 0209798

    Patients

    Seq Age Sex Outcome Treatment
    1