BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON TI ML 6/CART 120/BOX

    MDR report key: 24705538 · Received March 26, 2026

    Report

    Report Number
    3003898360-2026-00147
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 3, 2026
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    UDI-DI
    14026704725325
    PMA / PMN Number
    K982313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WHEN THE SURGEON CLIPS A VESSEL (CLOSES THE APPLIER), THE CLIP REMAINS STUCK TO THE APPLIER AND TEARS THE VESSEL WHEN THEY TRY TO REMOVE THE APPLIER. PATIENT ADMITTED FOR MAJOR SURGERY (HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY - HIPEC) DURING WHICH SIGNIFICANT BLOOD LOSS OCCURRED. THE MEDICAL REPORT STATES THAT THE DEVICE IS NOT SPECIFICALLY INVOLVED. BLOOD LOSS IS ESTIMATED AT 1.15 L WITH A URINE OUTPUT OF 1.8 L. THE PATIENT RECEIVED 12 L OF FLUID RESUSCITATION, INCLUDING 9.5 L OF NACL AND 2.5 L OF ISOFUNDIN, AS WELL AS 4 DOSES OF 20% ALBUMIN. THE PATIENT RECEIVED A TRANSFUSION OF 2 UNITS OF PACKED RED BLOOD CELLS DURING THE OPERATION. PATIENT ADMITTED TO THE ICU POST-OPERATIVELY WITH CLOSE MONITORING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765254 HORIZON TI ML 6/CART 120/BOX CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL IPN920981 73F2500764 14026704725325

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female NONE REPORTED.