BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING

    MDR report key: 19813111 · Received July 23, 2024

    Report

    Report Number
    9617594-2024-00923
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 19, 2024
    Report Date
    September 20, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709087712
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION. D9 - DEVICE AVAILABLE FOR EVALUATION - NO. INVESTIGATION SUMMARY NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT OF LEAKING AT BONDED PART OF MANIFOLD, 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. LOT HISTORY REVIEW THE DEVICE HISTORY REVIEW FOR LOT 13959229 WAS REVIEWED AND NO NONCONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION HOWEVER IT HAS NOT YET BEEN RECEIVED. H10 - AND 9617594-2024-00922-00.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT THERE WAS LEAKING AT BONDED PART OF MANIFOLD. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363523 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13959229 00887709087712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown