BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    43 CM (17") BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), PLUG ADAPTER

    MDR report key: 21669516 · Received March 21, 2025

    Report

    Report Number
    9617594-2025-00533
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 13, 2025
    Report Date
    April 28, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619070076
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THE COMPLAINT COULD NOT BE CONFIRMED BY INVESTIGATION. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NONCONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS PENDING COMPLETION. UPON COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED REGARDING A 43 CM (17") BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), PLUG ADAPTER THAT EXPERIENCED CRACK AND LEAKAGE. THE REPORTER STATED, ¿CONNECTION CRACKED LEAKING THE FLUID WHILST INFUSING FROM CONNECTION SITE, YES CRACKS NOTED ON LINE HUB.¿ THERE WAS PATIENT INVOLVEMENT, THERE WAS UNKNOWN DELAY IN THERAPY, AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139367 43 CM (17") BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), PLUG ADAPTER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14134614 00840619070076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown