BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

    MDR report key: 16153500 · Received January 12, 2023

    Report

    Report Number
    1423507-2023-00036
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    June 13, 2022
    Report Date
    January 12, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    FQH
    UDI-DI
    00382909101003
    PMA / PMN Number
    K202071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRO CODES: FQH (LAVAGE, JET) AND FRO (DRESSING, WOUND, DRUG). NO PHOTOS OR PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE INCIDENT COULD NOT BE VERIFIED. THE REPORTED LOT'S (1854590) 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

    WHILE SQUEEZING THE SURGIPHOR BOTTLE IT BROKE WITH ABOUT 50ML REMAINING IN THE BOTTLE. THE BREAK WAS ON THE BOTTLE ALONG THE SIDE, NOT SURE IF SEAM OR NOT. KIND OF SHATTERED NO EFFECT AS OF YET. SOME SOLUTION SPLATTERED ON OVERHEAD LIGHTS, THEN DRIPPED ON FIELD. MINIMAL DELAY REMAINDER OF SOLUTION USED FOR IRRIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750871 BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM SURGIPHOR FQH CAREFUSION, INC 910100 1854590 00382909101003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown