BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER

    MDR report key: 21368246 · Received February 12, 2025

    Report

    Report Number
    9617594-2025-00275
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 1, 2025
    Report Date
    April 28, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709095854
    PMA / PMN Number
    K964435
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION; A DEVICE HISTORY WILL BE REVIEWED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY ONE (1) USED SAMPLE LIST #B1115, 12" WAS RETURNED FOR EVALUATION. AS RETURNED THE TUBE WAS SEPARATED FROM THE FILTER PORT ON THE FILTER. BOTH COMPONENTS WERE OBSERVED THROUGH UV LIGHT AND NO SOLVENT MARKS WERE OBSERVED. THE OUTER DIAMETER OF THE SEPARATED TUBE WAS MEASURED AND IS WITHIN SPECIFICATION. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. COMPLAINT OF LEAKING IS CONFIRMED FROM THE RETURNED SAMPLE EVALUATION. THE PROBABLE CAUSE IS DUE TO AN INSUFFICIENT SOLVENT APPLIED DURING MANUAL PROCESS ASSEMBLY IN ENSENADA.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE DEVICE LEAKED AT THE FILTER DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, A DELAY IN THERAPY AND THE PATIENT REQUIRED A BLOOD TRANSFUSION. ADDITIONAL INFORMATION IS BEING REQUESTED. THE EXACT DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966494 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13623704 00887709095854

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention