BEUDAMED
    FDA Adverse Event Other Summary report: N

    RATCHET CLIPS, SOFT/SOFT, STRAIGHT, 8MM

    MDR report key: 217925 · Received April 6, 1999

    Report

    Report Number
    2027111-1999-00006
    Event Type
    Other
    Date Received
    April 6, 1999
    Date of Event
    July 20, 1998
    Report Date
    April 6, 1999
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BLANKET RGA FOR G-8050 AND AVD-8000 VOLUNTARY RECALL. DURING THE PRODUCTION PROCESS, LOT NUMBER 98B424 OF MODEL G-8050 WAS REJECTED ON THE PRODUCTION FLOOR FOR ONE POUCH THAT HAD BEEN HEAT SEALED AND WAS FOUND DURING IN-PROCESS INSPECTION WITH PERFORATIONS ON THE MYLAR SIDE ON THE POUCH. THE REASON FOR THE RECALL IS THAT THE POUCHES COULD POTENTIALLY BECOME PERFORATED BY A NON-RADIUSED CORNER ON THE RATCHET CLIP, WHICH COULD COMPROMISE THE STERILE BARRIER. NO DEVICE MALFUNCTION, PATIENT RELATED INJURY OR COMPLICATION WERE REPORTED OR ASSOCIATED WITH THIS RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RATCHET CLIPS, SOFT/SOFT, STRAIGHT, 8MM SURGICAL CLAMP DXC APPLIED MEDICAL RESOURCES AVD-8000 MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other