BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    132" (335 CM) APPX 17.4 ML, 20 DROP ADMIN SET W/3 CLAVE¿ CLEAR, REMV 3-GANG NANO

    MDR report key: 20813837 · Received November 30, 2024

    Report

    Report Number
    9617594-2024-01711
    Event Type
    Malfunction
    Date Received
    November 30, 2024
    Date of Event
    October 29, 2024
    Report Date
    December 30, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709122895
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTOGRAPH WAS RETURNED FOR EVALUATION. THE CUSTOMER'S REPORTED CONDITION OF CRACK/BREAK WAS ABLE TO BE CONFIRMED THROUGH THE PHOTO SAMPLE. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. LOT HISTORY REVIEW WAS PERFORMED AND THERE WERE NO NON-CONFORMANCE'S FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. HOWEVER, PHOTOGRAPHS WERE PROVIDED BY THE CUSTOMER AND EVALUATION OF THE PHOTOS IS PENDING.

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT INVOLVED A 132" (335 CM) APPX 17.4 ML, 20 DROP ADMIN SET W/3 CLAVE¿ CLEAR, REMV 3-GANG NANOCLAVE¿ STOPCOCK W/BASEPLATE, SPIN LUER, 2 EXT. IT WAS REPORTED THAT THE 3-GANG NANOCLAVE BROKE OFF WHERE THE STRING WAS ATTACHED. THE ISSUE HAPPENED POST-CASE, WHILE REMOVING THE LINES FOR DISPOSAL. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO HUMAN HARM AND NO DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618066 132" (335 CM) APPX 17.4 ML, 20 DROP ADMIN SET W/3 CLAVE¿ CLEAR, REMV 3-GANG NANO STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13972370 00887709122895

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown