BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SURGIPHOR - SURGIRINSE

    MDR report key: 15174277 · Received August 5, 2022

    Report

    Report Number
    1423507-2022-00015
    Event Type
    Injury
    Date Received
    August 5, 2022
    Date of Event
    July 12, 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
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 0

    PHOTO AND PHYSICAL SAMPLES WERE RECEIVED BY OUR QUALITY TEAM 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. THE REPORTED LOT'S (1854590) DEVICE HISTORY RECORDS WERE REVIEWED. ALL PROCESS AND FINAL INSPECTIONS MEET SPECIFICATIONS. AN IN-DEPTH INVESTIGATION 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. THIS INVESTIGATION IS ON-GOING AS WE CONTINUE TO LEARN MORE ABOUT THE PROBABLE ROOT CAUSES. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE SURGIPHOR BOTTLE "EXPLODED" WHILE UTILIZING ON TJA. VERBATIM: SURGIPHOR BOTTLE "EXPLODED" WHILE UTILIZING ON TJA. HCP WORRIED PLASTIC COULD OF FELL INTO OPEN INCISION. NO PATIENT HARM, HCP WORRIED ABOUT EFFICACY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE SURGIPHOR BOTTLE "EXPLODED" WHILE UTILIZING ON TJA. VERBATIM: SURGIPHOR BOTTLE "EXPLODED" WHILE UTILIZING ON TJA. HCP WORRIED PLASTIC COULD OF FELL INTO OPEN INCISION. NO PATIENT HARM, HCP WORRIED ABOUT EFFICACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930355 BD SURGIPHOR - SURGIRINSE BD SURGIPHOR - SURGIRINSE FQH CAREFUSION, INC 910100 1854590 00382909101003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other