BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

    MDR report key: 24148991 · Received January 22, 2026

    Report

    Report Number
    1423507-2026-00010
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    November 15, 2025
    Report Date
    April 8, 2026
    Manufacturer
    CAREFUSION, INC
    Product Code
    FQH
    UDI-DI
    00382909101102
    PMA / PMN Number
    K221504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SURGIPHOR BOTTLE CRACKED DURING USE. THERE WAS NO PATIENT HARM REPORTED. NOTE, THE DATE OF EVENT (15-NOV-2025) IS CONSIDERED TO BE A BEST ESTIMATE. SECTION C. 1A NAME AND STRENGTH: 0.5% POVIDONE IODINE (PVP-I) IN PHOSPHATE-BUFFERED SALINE, POTASSIUM IODIDE, AND VITAMIN E TPGS. SECTION D. 2B PROCODE: FQH (LAVAGE, JET) AND FRO (DRESSING, WOUND, DRUG). NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    PER MEDSUN REPORT (B)(4): "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
    297740 BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM SURGIPHOR FQH CAREFUSION, INC 4297341 00382909101102

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female