BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

    MDR report key: 16154725 · Received January 12, 2023

    Report

    Report Number
    1423507-2023-00046
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    August 2, 2022
    Report Date
    January 27, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    FQH
    UDI-DI
    00382909101003
    PMA / PMN Number
    K202071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE MADE TO THE SECTIONS TITLED 'DEVICE RETURNED TO MANUFACTURER' AND 'DEVICE EVAL BY MANUFACTURER' (DEVICE MANUFACTURERS ONLY (H)) H3 OTHER TEXT : SEE NARRATIVE BELOW

    Additional Manufacturer Narrative · 0

    SECTION D 2B PRO CODES: FQH (LAVAGE, JET) AND FRO (DRESSING, WOUND, DRUG) A PHOTO OF THE CRACKED INCIDENT WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE RETURNED PHOTO WAS VISUALLY INSPECTED AT BECTON DICKINSON AND THE CRACKED INCIDENT COULD BE VERIFIED. THE REPORTED LOT'S (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 THEY HAD TWO SURGIPHOR PACKAGES WITH VISIBLE LEAKING WITHIN THE STERILE PACKAGING; TWO BURST WHILE BEING USED IN SURGERY. VERBATIM: TWO SURGIPHOR PACKAGES HAD VISIBLE LEAKING WITHIN THE STERILE PACKAGING. TWO SURGIPHOR'S BURST WHILE BEING USED IN SURGERY, CAUSING THE BETADINE TO SPLASH ALL OVER THE SURGEON AND SCRUB TECH. NO IMPACT ON PATIENT; SURGEON USED THE SURGIPHOR UNTIL IT BURST; LEAKING SURGIPHOR PACKAGES WERE NOT USED. WHEN PRESSURE WAS APPLIED, THE SURGIPHOR BOTTLES BURST IN THE MIDDLE OF THE BOTTLE (PLEASE SEE ATTACHED PHOTO). ADDITIONALLY, THERE WERE TWO INDIVIDUAL SURGIPHOR PACKAGES THAT WERE VISIBLY LEAKING WITHIN THE STERILE PACKAGING (PLEASE SEE ATTACHED PHOTO). THOSE WERE THROWN AWAY AND REPLACED.

    Description of Event or Problem · 0

    TWO SURGIPHOR'S BURST WHILE BEING USED IN SURGERY, CAUSING THE BETADINE TO SPLASH ALL OVER THE SURGEON AND SCRUB TECH NO IMPACT ON PATIENT; SURGEON USED THE SURGIPHOR UNTIL IT BURST. WHEN PRESSURE WAS APPLIED, THE SURGIPHOR BOTTLES BURST IN THE MIDDLE OF THE BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075004 BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM SURGIPHOR FQH CAREFUSION, INC 910100 1854588 00382909101003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown