BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 CM (12") APPX 3.2 ML, SET AMBRATO PER INFUSIONE, 4 CLAVE®, PERFORATORE CON FI

    MDR report key: 19354740 · Received May 20, 2024

    Report

    Report Number
    9617594-2024-00635
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 23, 2024
    Report Date
    June 28, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619009359
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION, BUT IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    ONE (1) USED. LIST #011-H1368 WAS RETURNED FOR EVALUATION ON 6/12/24. AS RECEIVED ONE OF THE CLAVE ADAPTOR WAS SEPARATED FROM TRIFURCATED. THE SEPARATED PARTS WERE OBSERVED THROUGH UV LIGHT AND NOT ENOUGH PRESENCE OF SOLVENT COVERAGE WAS CONFIRMED. NO DAMAGE OR EXCESSIVE FORCE BEING APPLIED WAS OBSERVED ON THE SAMPLE. THE REST OF THE CLAVE ADAPTORS WERE TORQUE TESTED AND ONLY ONE OF THEM FAILED THE PRODUCT SPECIFICATION. COMPLAINT OF SEPARATION CAN BE CONFIRMED. THE PROBABLE CAUSE WAS DUE TO INSUFFICIENT SOLVENT APPLIED DURING MANUAL PROCESS ASSEMBLY DURING MANUFACTURING. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 30 CM (12") APPX 3.2 ML, SET AMBRATO PER INFUSIONE, 4 CLAVE®, PERFORATORE CON FILTRO WHERE THE CUSTOMER REPORTED THAT THE CYTOTOXIC (EPIRUBICIN) WAS DISPERSED ONTO THE NURSE AND THE ENVIRONMENT( FLOOR, SHOES, ETC.). THE INCIDENT CAUSED MINOR BURNS TO THE NURSE'S HANDS (EVEN WITH GLOVES) AND FOREARMS; THE CUSTOMER STATED THAT THE INCIDENT RESULTED IN GENERAL ANXIETY, AND THAT THE LEAK WAS CLEANED ACCORDING TO THE FACILITY'S PROTOCOL. THE CUSTOMER ALSO STATED THAT THE INCIDENT OCCURRED AT THE DEPARTMENT HDJ (HOSPITALISATION_DE_JOUR - DAY CARE UNIT) AT 4:06PM. THE CUSTOMER FURTHER STATED THAT THE DEVICE WAS NOT RECYCLED OR RESTERILISED BEFORE USE AND THAT THIS IS A RECURRING PROBLEM; THERE¿S NO GLUE AND THE VALVES COME OFF. THERE WAS A DELAY IN THERAPY FOR 1 HOUR; THE THERAPY WAS SUCCESSFUL WITH A LOWER DOSE DUE TO FLUID LOSS. THE DEVICE WAS CONNECTED TO THE PATIENT AT THE TIME OF THE EVENT, THERE WAS EXPOSURE TO THE CYTOTOXIC PRODUCT FOR THE PATIENT, THE PATIENT WAS NOT HARMED, NO NEED FOR ADDITIONAL MEDICAL INTERVENTION, NO BLOOD LOSS,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787491 30 CM (12") APPX 3.2 ML, SET AMBRATO PER INFUSIONE, 4 CLAVE®, PERFORATORE CON FI STOPCOCK, IV SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13766878 00840619009359

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EPIRUBICIN, MFR UNK