BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22340974 · Received June 26, 2025

    Report

    Report Number
    9617594-2025-01354
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    June 1, 2025
    Report Date
    August 20, 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

    ADDITIONAL INFORMATION D9. RECEIVED TWO (2) USED. LIST # B1115, 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER FOR INSPECTION. THE TUBING ON THE FILTER OUTLET WAS DISCONNECTED ON ONE OF THE SAMPLES. THE BOND WAS EXAMINED UNDER UV LIGHT AND THERE WAS NO EVIDENCE OF SOLVENT PRESENT. THE TUBING AND FILTER WERE WITHIN DIMENSIONAL SPECIFICATIONS. THE COMPLAINT OF FILTER DISCONNECTING FROM TUBING IS CONFIRMED ON ONE (1) SAMPLE. THE PROBABLE CAUSE OF THE TUBING SEPARATION IS INSUFFICIENT SOLVENT APPLIED DURING MANUAL BOND ASSEMBLY IN MANUFACTURING. THE COMPLAINT OF FILTER DISCONNECTING CANNOT BE REPLICATED OR CONFIRMED ON ONE (1) SAMPLE. A DEVICE HISTORY LOT REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WAS FOUND TO HAVE EXPERIENCED A DISCONNECT AT THE POINT OF THE FILTER. THERE WAS NO PATIENT HARM REPORTED. THE INITIAL REPORTER INDICATED THAT THE EVENT OCCURRED TWICE; HOWEVER, NO ADDITIONAL INFORMATION WAS GIVEN PERTAINING TO THE ADDITIONAL INSTANCES. A SEARCH OF THE COMPLAINT DATABASE SHOWED NO PRIOR REPORT OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538075 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. NOT PROVIDED 00840619045524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown