BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

    MDR report key: 22816965 · Received August 15, 2025

    Report

    Report Number
    1423507-2025-00044
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 24, 2025
    Report Date
    April 1, 2026
    Manufacturer
    CAREFUSION, INC
    Product Code
    FQH
    UDI-DI
    00382909101102
    PMA / PMN Number
    K221504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT THE SURGIPHOR BOTTLES CRACKED DURING USE. NO HEALTH CONSEQUENCES WERE REPORTED. 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). THIS MDR REPRESENTS THE SURGIPHOR BOTTLES OF LOT #5097205. ADDITIONAL MDR WAS SUBMITTED TO REPRESENT THE SURGIPHOR BOTTLES OF LOT #4260167. 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

    AS REPORTED, THE SUGIPHOR BOTTLES CRACKED WHEN SQUEEZED IN THE PROCEDURE. NO HEALTH CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99531 BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM SURGIPHOR FQH CAREFUSION, INC 5097205 00382909101102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown