BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWABCAP

    MDR report key: 22439155 · Received July 8, 2025

    Report

    Report Number
    MW5172399
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 12, 2025
    Report Date
    July 2, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    QBP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FLUSHED PT'S IV WITH SALINE FLUSH DUE TO ANTIBIOTIC BEING COMPLETE AND REMOVED AN ORANGE SWAB CAP FROM THE PACKAGE AND WHEN I OPENED IT AND INSPECTED IT, I NOTICED THAT THERE WAS BROWN/BLACK RESIDUE ON THE INSIDE OF THE PACKAGING. WHEN I TOUCHED IT, SOME RESIDUE CAME OFF ON MY GLOVE. I THREW THE SWAB CAP AWAY ALONG WITH THE REST OF THE PACKAGE AND I OPENED A NEW PACKAGE OF SWAB CAPS. UPON INSPECTING A CAP THAT I TOOK FROM THAT PACKAGE, THERE DID NOT APPEAR TO BE ANY RESIDUE ON THE CAP, AND ONE WAS PLACED ON HUB OF PT'S PICC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147691 SWABCAP CAP, DEVICE DISINFECTANT QBP ICU MEDICAL, INC. 14205937

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male