BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PARKER

    MDR report key: 13334456 · Received January 24, 2022

    Report

    Report Number
    3014527682-2022-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    January 4, 2022
    Report Date
    January 24, 2022
    Manufacturer
    ASPEN SURGICAL
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE 15 BLADE IS A COMPONENT CONTAINED WITHIN ROI CPS, LLC CONVENIENCE KIT 880118, LOT 90086.

    Description of Event or Problem · 0

    THE 15 BLADE SNAPPED IN HALF WHEN REMOVING FROM HANDLE. THERE WAS PATIENT CONTACT, BUT THE BLADE SNAPPED ONCE THE PROCEDURE WAS FINISHED. THERE WAS NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177620 BARD PARKER BLADE SURG RIB BCK CARB 15 BLADE GES ASPEN SURGICAL 371115 260152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown