BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 22726439 · Received August 6, 2025

    Report

    Report Number
    22726439
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    May 15, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    2 (J-LOOPS) 7" SMALLBORE PRESSURE INFUSION EXT [EXTENSION] SET WITH REMV MICRO-CLAVE. LEAKING FOUND AT CONNECTION TO PIV [PERIPHERAL IV] CATHETER WHEN FLUSHED. TO 2 J-LOOPS WHEN PUTTING IN PIV. LOT # 14134939 EXP. 2029-09-01 REF: MC33213. MANUFACTURER RESPONSE FOR 7" SMALLBORE PRESSURE INFUSION EXT SET W/ REMV MICROCLAVE CLEAR, PURPLE CLAMP RO, (BRAND NOT PROVIDED) (PER SITE REPORTER). YES, THEY WERE MADE AWARE ON [DATE REDACTED]. CURRENTLY AWAITING MANUFACTURER RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364865 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. MC33213 14134939

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Unknown