BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICU MEDICAL 7" APPX 0.30ML, SMALLBORE PRESSURE INFUSION EXT SET W/ REMV MICROCLA

    MDR report key: 21400601 · Received February 18, 2025

    Report

    Report Number
    MW5166363
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    February 11, 2025
    Report Date
    February 12, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CHANGED PIV(PERIPHERAL INTRAVENOUS LINE), J-LOOP FLUSHED WITHOUT ISSUE. PUT DRESSING ON SITE WAS CLEAN DRY AND INTACT. NOTED PINK DRAINAGE ON ONE SIDE OF DRESSING, FLUSHED AGAIN AND NOTED SCANT DRAINAGE UNDER DRESSING. TOOK DRESSING OFF, NOTED J-LOOP SECURE TO IV CATHETER, UNABLE TO SEE WHERE LEAKING WAS FROM. CHANGED J-LOOP, INITIAL FLUSH PRIOR TO ATTACHING TO PT, NO LEAK NOTED. ATTACHED TO CATHETER, NOTED SCANT LEAK. CHANGED J-LOOP AGAIN WITHOUT CONTINUED LEAKING. BOTH (J-LOOPS) WHICH LEAKED ARE FROM ICU MEDICAL. INC. (7" SMALLBORE PRESSURE INFUSION EXT SET W/REMV MICROCLAVE CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING) REF MC33038 LOT 14163930, EXPIRES 01/01/2029 038. REFERENCE REPORT MW5166364.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572677 ICU MEDICAL 7" APPX 0.30ML, SMALLBORE PRESSURE INFUSION EXT SET W/ REMV MICROCLA SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. MC33038 14163930

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention