BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22311576 · Received June 23, 2025

    Report

    Report Number
    9617594-2025-01314
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    May 19, 2025
    Report Date
    August 8, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619045524
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, TESTING HAS NOT YET BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED LIST #B1115, 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; LOT #UNKNOWN. NO VISUAL DAMAGES OR ANOMALIES WERE OBSERVED THE REPORTED COMPLAINT OF A LEAK COULD BE CONFIRMED. THE RETURNED SAMPLE WAS TESTED AND A LEAK WAS OBSERVED ON THE FILTER. THE PROBABLE CAUSE OF THE LEAK IS FROM THE TEMPORARY LOSS OF HYDROPHOBIC PROPERTIES. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS IDENTIFIED.

    Description of Event or Problem · 0

    A LUER LOCK CAP FROM A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER REPORTEDLY CRACKED AND LEAKED LIQUIDS NEAR THE CONNECTION SITE DURING PATIENT USE. THE ITEM WAS PULLED FROM PATIENT USE. THERE WAS NO REPORT OF ANY HUMAN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671188 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. UNKNOWN 00840619045524

    Patients

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