BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60" (152 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP,

    MDR report key: 19997459 · Received August 15, 2024

    Report

    Report Number
    9617594-2024-01146
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    May 19, 2024
    Report Date
    August 15, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709072503
    PMA / PMN Number
    K964435
    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

    D1. DEVICE NAME: 60" (152 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK WITHOUT A LOT NUMBER THE EXPIRATION AND MANUFACTURING DATES ARE UNKNOWN. INVESTIGATION SUMMARY NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT OF A TUBING CONNECTION FROM MICROBORE TUBING TO PALL FILTER WAS LEAKING COULD NOT BE CONFIRMED BY INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. A LOT HISTORY REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS IDENTIFIED.

    Description of Event or Problem · 0

    AN EVENT INVOLVING A 60" (152 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK EXPERIENCED LEAKAGE. IT WAS REPORTED THAT THIS WAS AN INCIDENT FOR ITEM BOPMC33932 ICU MEDICAL MICROBORE TUBING AND ITEM IME10011865 BD PAL FILTER WHEN USED TOGETHER. UPON TRACING TUBING FOR DUAL SIGN NICARDIPINE RATE CHANGE, NOTICED THAT TUBING CONNECTION FROM MICROBORE TUBING TO PALL FILTER WAS LEAKING. TUBING WAS CHANGED AND SAQ WAS NOTIFIED. THE MATING DEVICE IS A BD PAL FILTER WITH LIST NUMBER 10011865 AND LOT NUMBER (10)24029420. THE EVENT HAPPENED ON 19-MAY-2024. SAMPLE IS AVAILABLE FOR RETURN. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350728 60" (152 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 00887709072503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown IME10011865 PAL FILTER, BD