BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX TRANSTAR KITS

    MDR report key: 22026524 · Received May 15, 2025

    Report

    Report Number
    1526863-2025-00053
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    December 29, 2024
    Report Date
    May 15, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    DPT
    UDI-DI
    10351688503992
    PMA / PMN Number
    K942377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9616567-2025-00016-00. THE DATE OF THAT SUBMISSION WAS 04-FEB-2025. H3: FOUR USED SAMPLES WERE RECEIVED FOR EVALUATION. FOR THE FIRST SAMPLE, WHEN THE END OF THE TUBING WAS EXAMINED, INSUFFICIENT SOLVENT COVERAGE WAS OBSERVED. NO ANOMALIES WERE OBSERVED ON THE OTHER THREE SAMPLES. DURING THE FUNCTIONAL TESTING, ON THE FIRST SAMPLE, LEAKAGE WAS OBSERVED DURING TESTING. FOR THE OTHER THREE SAMPLES, WHEN THE SETS WERE PRIMED AND PRESSURE LEAK TESTED, NO LEAKS WERE OBSERVED. THE CUSTOMER REPORTED COMPLAINT WAS ABLE TO BE CONFIRMED BASED ON THE TEST RESULTS. NO DISCREPANCIES OR ANOMALIES WERE OBSERVED DURING THE MANUFACTURING OF THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD FLUID LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346013 MEDEX TRANSTAR KITS PROBE, BLOOD-FLOW, EXTRAVASCULAR DPT SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4468877 10351688503992

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown