BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    42 CM (17") PUR SET LINEARE, PERFORATORE CON VALVOLA, Y-CLAVE, FILTRO TAXOLO, L

    MDR report key: 11228548 · Received January 26, 2021

    Report

    Report Number
    9617594-2021-00014
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    January 1, 2021
    Report Date
    January 7, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619020170
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY REVIEW (DHR) WAS REVIEWED AND THERE WERE NO RELEVANT 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 IN SECTION D9.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 42 CM (17 ") PUR LINEAR SET, PERFORATOR WITH VALVE, Y-CLAVE®, TAXOLO FILTER, LUER LOCK GIR THAT THE CUSTOMER REPORTED THE BLUE LOCK CAP CAME OFF DURING USE WITH CONSEQUENT SPREAD OF ANTIBLASTIC DRUGS. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF ADVERSE EVENT. THIS CAPTURES THE SECOND OF TWO EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127909 42 CM (17") PUR SET LINEARE, PERFORATORE CON VALVOLA, Y-CLAVE, FILTRO TAXOLO, L STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4936600 00840619020170

    Patients

    Seq Age Sex Outcome Treatment
    1