BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22" (56 CM) ADD-ON 150 ML BURETTE SET (MICROCLAVE®, NO SHUT-OFF), W/SPIROS®, 2 C

    MDR report key: 17720448 · Received September 11, 2023

    Report

    Report Number
    9617594-2023-00678
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    August 1, 2023
    Report Date
    November 16, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709076013
    PMA / PMN Number
    K081361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED. LIST #CH3554, 22" (56 CM) ADD-ON 150 ML BURETTE SET (MICROCLAVE®, NO SHUT-OFF), W/SPIROS®, 2 CLAMPS, VENTED CAP; LOT #13657290. THE COMPLAINT OF LEAKAGE AND SEPARATION CAN BE CONFIRMED ON THE RETURNED DEVICE. AS RECEIVED THE BASE OF THE BURETTE WAS SEPARATED. THE BONDING LOCATION ON EACH BURETTE WAS EXAMINED. INSUFFICIENT SOLVENT COVERAGE OBSERVED. THE PROBABLE CAUSE OF THE SEPARATION AND LEAKAGE IS DUE TO INSUFFICIENT SOLVENT BEING APPLIED DURING MANUAL SUPPLIER'S PROCESS ASSEMBLY. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION IS PENDING.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 22" (56 CM) ADD-ON 150 ML BURETTE SET (MICROCLAVE®, NO SHUT-OFF), W/SPIROS®, 2 CLAMPS, VENTED CAP WHERE IT WAS REPORTED THAT THE BURETTE WAS LEAKING FROM THE BOTTOM. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS NORMAL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS THE FIRST OF TWO EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143283 22" (56 CM) ADD-ON 150 ML BURETTE SET (MICROCLAVE®, NO SHUT-OFF), W/SPIROS®, 2 C SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13657290 00887709076013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown