BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    41 CM (16") PUR TRANSFER SET W/CLAVE® CLEAR, CHECK VALVE W/LUER LOCK, FILTER CAP

    MDR report key: 8968796 · Received September 6, 2019

    Report

    Report Number
    9617594-2019-00300
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 2, 2019
    Report Date
    August 12, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619088842
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ONE (1) USED UNIT LIST # 011-MC9077, 41 CM (16") PUR TRANSFER SET W/CLAVE® CLEAR, CHECK VALVE W/LUER LOCK, FILTER CAP, 5 UNITS; LOT # 3811485 WAS RECEIVED ON 9/3/2019 FOR EVALUATION. THE SINGLE USED TRANSFER SET WAS RETURNED WITH THE Y-CLAVE SILICONE SEAL STUCK DOWN. SUBSEQUENT INVESTIGATION REVEALED THE SPIKE WAS DRY WITHOUT LUBRICATION THAT RESULTED IN A DRY SPIKE STICK DOWN. THE COMPLAINT WAS CONFIRMED. THE PROBABLE CAUSE IS NO SPIKE/SEAL LUBRICANT APPLICATION DURING AUTOMATED ASSEMBLY IN SALT LAKE CITY. THE DEVICE HISTORY REVIEW FOR LOT NUMBER 3811485 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE IS BEING RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ACCIDENTAL LEAKAGE OF CARMUSTINE CYTOSTATIC FROM A PUR TRANSFER SET W/CLAVE CLEAR, CHECK VALVE W/LUER LOCK, FILTER CAP. THE LEAK OCCURRED WHEN THE MEDICAL TECHNICIAN HUNG THE INFUSION SOLUTION. THE SPILL WAS ON THE FLOOR, ON THE HOSPITAL BED, AND SOMETHING ON THE PATIENT¿S CLOTHES. THERE WAS NO REPORTED HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764149 41 CM (16") PUR TRANSFER SET W/CLAVE® CLEAR, CHECK VALVE W/LUER LOCK, FILTER CAP STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3811485 00840619088842

    Patients

    Seq Age Sex Outcome Treatment
    1 CARMUSTINE, UNK MFR