BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 1200CC HIFLOW SUCTION CANISTER

    MDR report key: 1906688 · Received November 15, 2010

    Report

    Report Number
    2133713-2010-00004
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    USER PROVIDED PHOTO OF PRODUCT SERIAL NUMBER ((B)(4)). PRODUCT IS OLDER THAN 2002 (THE EARLIEST RECORDS STILL RETAINED.) ESTIMATE PRODUCT IS 9-10 YRS OLD. REPORTED FAILURE IS CONSISTENT WITH UV EMBRITTLEMENT. SINCE 2007, THIS PRODUCT BEARS A THREE YR EXP PERIOD. USER REPORTED THAT THEY ARE IMPLEMENTING A PM PROCESS TO CHANGE OUT CANISTERS DURING ANNUAL PM.

    Description of Event or Problem · 1

    USER WAS PERFORMING PM ON PORTABLE SUCTION EQUIPMENT WHEN THE LID 'BLEW UP' INTO PIECES. USER REPORTED THAT THE UNIT WAS IN STORAGE AND HAD NOT BEEN USED FOR A LONG TIME. INCIDENT OCCURRED IN ENGINEERING AREA, AND THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEMIS 1200CC HIFLOW SUCTION CANISTER APPARATUS, SUCTION, VACUUM POWERED KDQ BEMIS MFG. CO. 480410 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1