BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK ML CLIPS 6/CART 84/BOX

    MDR report key: 2961277 · Received January 28, 2013

    Report

    Report Number
    3003898360-2013-00051
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 17, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE NOT RECEIVED BY MFR IN TIME FOR THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED: AFTER THE CLOSURE OF 2 CLIPS ON THE RIGHT BRANCH OF THE HEPATIC ARTERY WITHOUT ANY ISSUE, ONE OF THE CLIPS OPENED. SURGEON RECOVERED IT (NOTHING REMAINED IN THE PATIENT). SURGEON DECIDED TO USE ANOTHER CARTRIDGE OF CLIPS WITH ANOTHER LOT NUMBER; NO OTHER ISSUES. NO CONSEQUENCES FOR THE PATIENT. PATIENT'S CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38080 HEMOLOK ML CLIPS 6/CART 84/BOX LIGATING CLIPS FZP TELEFLEX MEDICAL 01L1100463

    Patients

    Seq Age Sex Outcome Treatment
    1