BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 1200CC HIFLOW SUCTION CANISTER

    MDR report key: 3883107 · Received February 19, 2014

    Report

    Report Number
    2133713-2014-00005
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 19, 2014
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT WAS PHOTOGRAPHED AND SUBJECT TO FTIR ANALYSIS. FTIR INDICATED A HIGH DEGREE OF OXIDATION CONSISTENT WITH UV EMBRITTLEMENT. CUSTOMER STATED PRODUCT WAS FOUND IN STORAGE WHERE IT HAD REMAINED FOR AN INDETERMINATE TIME PERIOD. PROBABLE CAUSE OF FAILURE: UV EMBRITTLEMENT DUE TO EXCESSIVE UV EXPOSURE. SINCE (B)(4) 2007 THIS PRODUCT BEARS A THREE-YEAR EXPIRATION DATE. SINCE (B)(4) 2011 THE PLASTIC USED IN THE CANISTER COVER HAS A UV INHIBITOR AND ANTI-OXIDANT PACKAGE.

    Description of Event or Problem · 1

    A SUCTION UNIT THAT HAD BEEN OUT OF SERVICE FOR AN INDETERMINATE TIME WAS BROUGHT OUT AND TESTED AT FULL VACUUM AND THE CANISTER COVER IMPLODED. NO INJURY TO THE TECH DOING THE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103979 BEMIS 1200CC HIFLOW SUCTION CANISTER BOTTLE, COLLECTION, VACUUM KDQ BEMIS MFG. CO. 480410 20060313

    Patients

    Seq Age Sex Outcome Treatment
    1