BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 800CC HYDROPHOBIC CANISTER

    MDR report key: 1509230 · Received October 7, 2009

    Report

    Report Number
    2133713-2009-00008
    Event Type
    Malfunction
    Date Received
    October 7, 2009
    Date of Event
    September 17, 2009
    Report Date
    October 7, 2009
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THERE WERE TWO INCIDENTS REPORTED OF CANISTERS IMPLODING IN TWO DIFFERENT OR ROOMS. CANISTERS IMPLODED DURING PROCEDURES. THERE WERE NO PT CONSEQUENCES OR REPORTED INJURIES. A THIRD INCIDENT OCCURRED WITH A COMPETITOR'S CANISTER. COMPLAINANT STATES THEY ARE HAVING THEIR VACUUM SYSTEM CHECKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEMIS 800CC HYDROPHOBIC CANISTER APPARATUS, SUCTION, VACUUM POWERED KDQ BEMIS MFG. CO. 424410 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1