BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIPHOR

    MDR report key: 23921224 · Received December 30, 2025

    Report

    Report Number
    23921224
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 11, 2025
    Manufacturer
    CAREFUSION 2200, INC
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    NO HARM TO PATIENT. WHEN USING THE SURGIPHOR ANTIMICROBIAL IRRIGATION SYSTEM (REF #910110 LOT # 4297341, EXP DATE 09-30-2026), THE BOTTLE CRACKED WHILE IN SURGEON'S HAND BEING USED AS DIRECTED. THE WOUND WAS IRRIGATED WITH LARGE AMOUNT OF STERILE FLUID AND BOTTLE INSPECTED WITH ALL PIECES INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769582 SURGIPHOR LAVAGE, JET FQH CAREFUSION 2200, INC 910110 4297341

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female