BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIV PLUS SAFETY I.V. CATHETERS

    MDR report key: 22097303 · Received May 28, 2025

    Report

    Report Number
    3012307300-2025-06287
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    January 1, 2025
    Report Date
    December 11, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    H3/H6: FOUR HUNDRED AND SIXTY-TWO (462) UNOPENED, UNUSED 22G X 1¿ PROTECTIV SISTER SAMPLES WERE RETURNED FOR ANALYSIS (SKU# 305006 - 450 FROM LOT 6021646, 5 FROM LOT 4388013, 3 FROM LOT 4388003, 2 FROM LOT 4417418, AND 1 EACH FROM LOTS 4374634 AND 4388014). ALL EVALUATED SAMPLES WERE FOUND TO BE ACCEPTABLE WITHOUT FAILURE. BASED ON SISTER SAMPLE ANALYSIS, THE COMPLAINT CANNOT BE CONFIRMED. THE CAUSE OF THE REPORTED ISSUE WAS NOT DETERMINED AS NO ISSUE WAS IDENTIFIED THROUGH TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUB OF THE CATHETER EXHIBITED A LEAKAGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851110 PROTECTIV PLUS SAFETY I.V. CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM FOZ ICU MEDICAL, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown