BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ABS LINEDRAW DRY HEPARIN

    MDR report key: 23336780 · Received October 20, 2025

    Report

    Report Number
    1217052-2025-00103
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 23, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    D3: MFG. ESTABLISHMENT NAME UPDATED. H3: THE DEVICE WAS RECEIVED FOR EVALUATION. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED DUE TO LOGISTICAL ISSUES WITH THE CLOSURE OF THE KEENE SITE AND THEIR TRANSFER OF DHR RECORDS. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. THE CUSTOMER'S STATED PROBLEM WAS NOT CONFIRMED. NO LEAKS WERE OBSERVED. THERE WAS NO KNOWN CAUSE OF THE REPORTED ISSUE, AND NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKED INTO THE BAG. WHEN THE CAP WAS REMOVED, IT WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841955 PORTEX ABS LINEDRAW DRY HEPARIN TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA ICU MEDICAL, INC. 6055478

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown