BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 1200CC HIFLOW CANISTER

    MDR report key: 4270152 · Received November 12, 2014

    Report

    Report Number
    2133713-2014-00012
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 23, 2014
    Report Date
    November 12, 2014
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED DHR AND NO DISCREPANCIES FOUND. NO PRODUCT IS BEING RETURNED FOR ANALYSIS. NO INVENTORY OF THIS LOT REMAINS TO SAMPLE/TEST.

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT DURING SETUP FOR THE FIRST PT OF THE DAY, A SUCTION CANISTER IMPLODED. THERE WAS NO PT IN THE ROOM AND NO INJURY REPORTED. PERSONNEL IN THE ROOM HAD THEIR BACKS TO THE CANISTER AND DID NOT SEE WHAT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727952 BEMIS 1200CC HIFLOW CANISTER APPARATUS, SUCTION, VACUUM POWERED GCX BEMIS MFG. CO. 484410 20141002

    Patients

    Seq Age Sex Outcome Treatment
    1