BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, 3 STANDARDBORE/SMALLBORE EXT SETS, 4 GANG STOPCOCK W/POLE MOUNT, 13 MICROCL

    MDR report key: 10637001 · Received October 6, 2020

    Report

    Report Number
    9617594-2020-00431
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 2, 2020
    Report Date
    September 24, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709093737
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ONE (1) USED LIST# 011-MC330551, KIT (LOT# 4854812), ONE (1) USED INFUSION SET UNKNOWN MANUFACTURER, ONE (1) UNKNOWN PICC LINE, AND ONE (1) USED CONTAINER 100 ML 0.9% SODIUM CHLORIDE INJECTION, USP WERE RECEIVED ON (B)(6) 2020 AND VISUALLY INSPECTED. AS RECEIVED, NO MICROCLAVE SEALS ON ANY OF THE KIT SETS WERE STUCK DOWN. BLOOD RESIDUALS WERE PRESENT WITHIN THE HOUSING OF ONE OF THE Y-CLAVES AS RECEIVED. IT IS UNKNOWN HOW THE RESIDUALS WERE CREATED. NO OTHER DAMAGE OR ANOMALIES WERE IDENTIFIED. EACH EXTENSION SET INCLUDED IN THE 011-MC330551, KIT RETURNED WAS LEAK TESTED ACCORDING TO PRODUCT PERFORMANCE SPECIFICATIONS THROUGH EACH OF THE MICROCLAVES. NO LEAKS, AIR IN THE LINES OR SEAL STICK DOWNS OCCURRED. THE MALE LUER OF THE UNKNOWN EXTENSION SET WAS MEASURED AND FOUND TO BE COMPATIBLE WITH THE MICROCLAVE AND MEET ISO STANDARDS FOR FITTINGS. THE REPORTED COMPLAINT OF A STICK DOWN AND SUBSEQUENT AIR IN THE LINE COULD NOT BE REPLICATED OR CONFIRMED. A DEVICE HISTORY REVIEW FOR LOT# 4854812 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION. IT IS YET TO BE RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A KIT, 3 STANDARDBORE/SMALLBORE EXT SETS, 4 GANG STOPCOCK W/POLE MOUNT, 13 MICROCLAVE¿ CLEAR, 2 CHECK VALVES, 3 4-WAY STOPCOCKS, 3 ROTATING LUERS WHERE ONE OF THE BIDIRECTIONAL VALVES WAS STUCK ALLOWING THE AIR TO ENTER. THE STOPCOCK AND CENTRAL CATHETER, PROGRAMMED BEFORE THE INCIDENT, WERE REMOVED. THE EVENT OCCURRED DURING PATIENT USE, BUT NO ADVERSE EVENT, NO DELAY IN THERAPY, NO NEED FOR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099345 KIT, 3 STANDARDBORE/SMALLBORE EXT SETS, 4 GANG STOPCOCK W/POLE MOUNT, 13 MICROCL STOPCOCK, I.V. SET FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4854812 00887709093737

    Patients

    Seq Age Sex Outcome Treatment
    1