BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    40 CM (16") PUR AMBRATO SET LIN, PERF CON VALVOLA, Y-CLAVE®, FILTRO TAXOL E LL

    MDR report key: 19951871 · Received August 9, 2024

    Report

    Report Number
    9617594-2024-01113
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 8, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619019853
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO 011-H2589 PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DHR WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED. ADDITIONAL INFORMATION CAN BE FOUND IN D4.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. SECTION E INITIAL REPORTER (FULL) PHONE NUMBER: (B)(6).

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 40 CM (16") PUR AMBRATO SET LINEARE, PERFORATORE CON VALVOLA, Y-CLAVE®, FILTRO TAXOL E LL GIR. THE FOLLOWING ISSUE WAS REPORTED BY THE CUSTOMER: POOR SEALING OF THE Y-CLAVE VALVE AND LUER LOCK LOCATED AT THE END OF THE PIGTAIL. THERE WAS POSSIBLE LEAKAGE OF AN UNSPECIFIED DRUG. THERE WAS NO REPORT OF HUMAN HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2515703 40 CM (16") PUR AMBRATO SET LIN, PERF CON VALVOLA, Y-CLAVE®, FILTRO TAXOL E LL STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13543785 00840619019853

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED DRUG/INFUSATE, MRF UNK.