BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    186 CM (73") PUR SET D'INFUSIONE, PERF. CON VALVOLA, 2 ACCESSI CON BCV, CAMERA,

    MDR report key: 19244427 · Received May 3, 2024

    Report

    Report Number
    9617594-2024-00543
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 2, 2024
    Report Date
    May 3, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619019297
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 186 CM (73") PUR SET D'INFUSIONE, PERF. CON VALVOLA, 2 ACCESSI CON BCV, CAMERA, FILTRO 15, RUB. CON CLAVE¿, LL GIR GENERATED A LEAK DURING PATIENT USE. THE FOLLOWING ISSUE WAS REPORTED BY THE CUSTOMER: ¿WHEN CONNECTING THE TUBING, LEAK AT THE NON-RETURN VALVE¿. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT IS WHEN CONNECTING THE TUBING. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758585 186 CM (73") PUR SET D'INFUSIONE, PERF. CON VALVOLA, 2 ACCESSI CON BCV, CAMERA, STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13806474 00840619019297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED FLUID, UNK MFR.