BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    28 CM (11") APPX 2.5 ML, SET AMBRATO PER INFUSIONE 2 CLAVE® CONNECTOR, PERFORATO

    MDR report key: 8842060 · Received July 30, 2019

    Report

    Report Number
    9617594-2019-00247
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    July 11, 2019
    Report Date
    July 12, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619009342
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - ONE USED 011-H1367, 28 CM (11") SET AMBRATO PER INFUSIONE 2 CLAVE® CONNECTOR, PERFORATORE CON FILTRO; LOT # 3949512, WAS RETURNED FOR TESTING ON 8/6/2019. THE REPORTED PRODUCT PROBLEM FOR SEPARATION OF THE CLAVE FROM THE TRIFURCATED CONNECTOR WAS CONFIRMED. THIS WAS DUE TO INSUFFICIENT SOLVENT BONDING PRESENT. THE PROBABLE CAUSE WAS DUE TO AN ERROR IN THE MANUAL BONDING PROCESS DURING MANUFACTURING AT ENSENADA. THE DEVICE HISTORY REVIEW (DHR) FOR LOT NUMBER 3949512 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND. ADDITIONAL INFORMATION CAN BE FOUND IN SECTION B5, D11 AND G1. D11 - EXT SET TUBING PUR YELLOW WITH SPIKE, Y-CLAVE®, CLAMP, LUER CHECK VALVE, LN 011-H2771, MFR ICU MEDICAL, INC. UNSPEC PUMP.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO OBVIOUS DEFECT SEEN WHEN SETTING UP THE DEVICE. IT WAS UNKNOWN HOW LONG THE MEDICATION WAS INFUSING PRIOR TO THE PROBLEM BEING NOTICED. THE CHEMOTHERAPY BAG WAS CONNECTED VIA AMBER EXTENSION SET TUBING, 011-H2771, AND AN UNSPECIFIED PUMP WAS USED DURING THE EVENT, BUT THE CUSTOMER COULD NOT PROVIDE INFORMATION WITH REGARD TO PSI PRESSURE OF THE PUMP AND ANY ALARMS OCCURRED ON THE PUMP.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A TUBING SET THAT DURING INFUSION OF DOCETAXEL, A LEAK OF CHEMOTHERAPY WAS NOTED ON THE GROUND AND ON THE INFUSION PUMP. THE ADMINISTRATION SYSTEM WAS REPLACED. IT WAS REPORTED THAT THE PATIENT, ATTENDANT, AND NURSES WERE EXPOSED TO A CHEMOTHERAPY PRODUCT; ALTHOUGH THE PATIENT WAS NOT IN DIRECT CONTACT WITH THE PRODUCT, SPILLING ONTO THE FLOOR AND THE INFUSION PUMP. THERE WAS NO ADVERSE EVENT, NO DELAY IN CRITICAL THERAPY AND NO MEDICAL INTERVENTION NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636382 28 CM (11") APPX 2.5 ML, SET AMBRATO PER INFUSIONE 2 CLAVE® CONNECTOR, PERFORATO STOPCOCK, IV SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3949512 00840619009342

    Patients

    Seq Age Sex Outcome Treatment
    1 DOCETAXEL, MFR UNK.| DOCETAXEL, MFR UNK