BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCKESSON BRANDS

    MDR report key: 9779313 · Received March 3, 2020

    Report

    Report Number
    1451040-2020-00002
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    February 19, 2020
    Report Date
    March 2, 2020
    Manufacturer
    SHANGHAI JIANZHONG MEDICAL PACKAGING CO, LTD
    Product Code
    FRG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR SELF SEAL STERILIZATION POUCHES CAUGHT FIRE IN THEIR RITTER M7 SPEEDCLAVE AUTOCLAVE (SERIAL # (B)(4)). UPON OPENING THE MACHINE SHE NOTICED THAT THE BAGS WERE BURNING. SHE THEN PUT THE AUTOCLAVE ON A CART AND TOOK IT OUTSIDE. THE AUTOCLAVE WAS REPORTED TO BE 10 YEARS OLD. MCKESSON CONTACTED THE MANUFACTURER OF THE AUTOCLAVE TO BRING THIS TO THEIR ATTENTION AS WELL. THEY INDICATED THAT THE UNIT WAS BUILT AND SHIPPED IN 2003 (17 YEARS AGO). THEY INDICATED THAT THERE IS POTENTIAL FOR THE OPERATOR TO TURN THE UNIT ON WITHOUT WATER IN THE CHAMBER, WHICH WOULD RESULT IN THE CHAMBER GETTING VERY HOT. THERE IS ALSO THE POTENTIAL FOR A VALVE OR GASKET TO NOT SEAL COMPLETELY AND ALLOW THE WATER THAT WAS INITIALLY IN THE CHAMBER TO ESCAPE AND ALLOW THE CHAMBER TO GET VERY HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241814 MCKESSON BRANDS POUCH, SELF SEAL ECON 3.5X9 FRG SHANGHAI JIANZHONG MEDICAL PACKAGING CO, LTD CJZI11-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other