BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ABS PRO-VENT ARTERIAL BLOOD SAMPLING

    MDR report key: 23788725 · Received December 12, 2025

    Report

    Report Number
    3012307300-2025-13424
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    July 23, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED. THE REPORTED ISSUE CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS STATED IN THE REPORT THAT THE PATIENT'S PARTIAL PRESSURE OF CARBON DIOXIDE (PPO) WAS 170, REQUIRING A REPEAT BLOOD GAS TEST. THE NURSE DREW ARTERIAL BLOOD USING STANDARD PROCEDURES. WHEN THE CAP WAS ATTACHED TO RELEASE AIR, BLOOD LEAKED FROM THE CAP, RESULTING IN THE LOSS OF THE BLOOD SAMPLE. A NEW BLOOD SAMPLE WAS COLLECTED FROM THE PATIENT, AND NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2702467 PORTEX ABS PRO-VENT ARTERIAL BLOOD SAMPLING TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA ICU MEDICAL, INC. 6029224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown