BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESET¿ TRANSPAC IT W/03 ML RESERVOIR AND SINGLE NEEDLELESS VALVE, WITHOUT VELC

    MDR report key: 16934870 · Received May 15, 2023

    Report

    Report Number
    9617594-2023-00192
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 14, 2023
    Report Date
    April 17, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619035822
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9 - DATE RETURNED TO MFG ON 8/23/2023. RECEIVED ONE USED PARTIAL. LIST #011-46103-05, SAFESET¿ TRANSPAC IT W/03 ML RESERVOIR AND SINGLE NEEDLELESS VALVE, WITHOUT VELCRO ARM STRAP, PATIENT MOUNT; LOT #6024117. THE REPORTED COMPLAINT OF SEPARATION WAS CONFIRMED ON THE RETURNED SET. DURING VISUAL INSPECTION, THE SAFESET RESERVOIR AND THE 2- WAY STOPCOCK WAS RECEIVED SEPARATED. WHEN MICROSCOPICALLY EXAMINED, INSUFFICIENT ADHESIVE COVERAGE IN THE SAFESET RESERVOIR (INNER DIAMETER) LUER AND ON THE FEMALE LUER OF THE 2- WAY STOPCOCK WAS OBSERVED. THE LUER POCKET WAS NOT TACKY. THE PROBABLE CAUSE OF THE INSUFFICIENT ADHESIVE COVERAGE ON THE 2- WAY STOPCOCK LUER HAD OCCURRED DUE TO AND ERROR DURING ASSEMBLY AT MANUFACTURING. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION, HOWEVER, IT IS YET TO BE RECEIVED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A SAFESET¿ TRANSPAC IT W/03 ML RESERVOIR AND SINGLE NEEDLELESS VALVE, WITHOUT VELCRO ARM STRAP, PATIENT MOUNT WHERE IT WAS REPORTED THAT WHILE A PATIENT WAS BEING INVASIVELY MONITORED THROUGH AN ART LINE, THE BONDING BETWEEN THE SAMPLING PORT AND 2-WAY VALVE CAME APART RESULTING IN BLOOD FLUSHING THROUGH THE ART LINE. THERE WAS UNSPECIFIED MEDICATION BEING USED WITH THIS PRODUCT. THE EVENT OCCURRED AT 8AM. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184170 SAFESET¿ TRANSPAC IT W/03 ML RESERVOIR AND SINGLE NEEDLELESS VALVE, WITHOUT VELC TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6024117 00840619035822

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED MEDICATION, MFR UNK