BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    113" (287 CM) APPX 14.7 ML, 10 DROP ADMIN SET W/MICROCLAVE¿ CLEAR, REMV 4-WAY NA

    MDR report key: 20421403 · Received October 10, 2024

    Report

    Report Number
    9617594-2024-01423
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 1, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709120174
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE MULTIPLE ATTEMPTS WERE REQUESTED FOR THE DEVICE TO BE RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    NO AC233 PRODUCT SAMPLES, VIDEOS OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY REPORT (DHR) WAS NOT REVIEWED, NO LOT NUMBER INFORMATION WAS PROVIDED. THE COMPLAINT CANNOT BE CONFIRMED, WITHOUT THE RETURN OF THE USED SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 113" (287 CM) APPX 14.7 ML, 10 DROP ADMIN SET W/MICROCLAVE¿ CLEAR, REMV 4-WAY NANOCLAVE¿ STOPCOCK, REMV 2-GANG 4-WAY NANOCLAVE¿ STOPCOCKS, SPIN LUER, 2 EXT. THE REPORT STATED THAT THE STOPCOCKS ARE FALLING APART AND DISCONNECTING. THERE WAS NO REPORT OF ANY HUMAN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005190 113" (287 CM) APPX 14.7 ML, 10 DROP ADMIN SET W/MICROCLAVE¿ CLEAR, REMV 4-WAY NA STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN 00887709120174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown