BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 1200CC HI-FLOW SUCTION CANISTER

    MDR report key: 3937460 · Received April 15, 2014

    Report

    Report Number
    2133713-2014-00009
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    February 24, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT DATE IS APPROXIMATELY NINE MONTHS PAST THE PRODUCT'S LABELED EXPIRATION DATE. PROBABLE CAUSE IS UV EMBRITTLEMENT. SINCE (B)(6) 2011, THIS PRODUCT HAS BEEN MANUFACTURED WITH A UV INHIBITOR AND ANTI-OXIDANT.

    Description of Event or Problem · 1

    COMPLAINANT STATED CANISTER IMPLODED DURING A ROUTINE TEST OF VACUUM PUMP ON A CRASH CART. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228961 BEMIS 1200CC HI-FLOW SUCTION CANISTER APPARATUS, SUCTION, VACUUM POWERED GCX BEMIS MFG. CO. 484410 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1