BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

    MDR report key: 16140551 · Received January 11, 2023

    Report

    Report Number
    1423507-2023-00024
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    June 8, 2022
    Report Date
    January 11, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    FQH
    UDI-DI
    00382909101003
    PMA / PMN Number
    K202071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRO CODES: FQH (LAVAGE, JET) AND FRO (DRESSING, WOUND, DRUG). PHOTO AND PHYSICAL SAMPLES FOR EVALUATION. THE RETURNED COMPLAINT SAMPLES WERE VISUALLY INSPECTED AT BECTON DICKINSON. THE CRACKS WITH THE SURGIPHOR CONTAINERS WERE OBSERVED TO ALL OCCUR AT THE SAME GENERAL LOCATION. ALL OF THE COMPLAINT SAMPLES HAD A CRACK ON THE SAME SIDE OF THE SURGIPHOR CONTAINER, NEAR THE EMBOSSED ¿S¿ OF ¿SURGIPHOR¿ AT THE TOP OR BOTTOM OF THE CONTAINER. MORE SPECIFICALLY, THE CRACK IS ALWAYS PRESENT AT THE UPPER EDGE OR THE LOWER EDGE OF THE AREA DESIGNED AS A HAND GRIP. THESE COMPLAINT SAMPLES WERE THEN EVALUATED USING COMPUTERIZED TOMOGRAPHY (CT) SCANNING. THE CT TESTING DEMONSTRATED THAT CRACKS WITHIN THE SURGIPHOR CONTAINER WAS OBSERVED TO OCCUR IN THE SAME GENERAL LOCATION OF THE CONTAINER. THIS LOT (1854588) DEVICE HISTORY RECORDS WERE REVIEWED. ALL PROCESS AND FINAL INSPECTIONS MEET SPECIFICATIONS. A CAPA HAS BEEN OPENED FOR THIS ISSUE. AN IN-DEPTH INVESTIGATION AS PART OF THAT CAPA HAS BEEN PERFORMED TO IDENTIFY THE CAUSE OF THE SURGIPHOR BOTTLE CRACKING DURING USE. AT THIS TIME THIS INVESTIGATION DISCOVERED THAT THE COMBINATION OF THE FOLLOWING VARIABLES ARE PROBABLE CAUSES THAT CONTRIBUTE TO THE FAILURE MODE OF SURGIPHOR CONTAINERS CRACKING DURING USE: AGING, BOTTLE WALL THICKNESS/BOTTLE WEIGHT, INSPECTED PRODUCT RETURNED INTO THE MANUFACTURING LOT, AND UPPER END OF THE GAMMA STERILIZATION DOSAGES OF THE PRODUCT. A FOLLOW-UP WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT 3 SURGIPHOR BOTTLES CRACKED WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908573 BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM SURGIPHOR FQH CAREFUSION, INC 910100 1854588 00382909101003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other