BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 1200CC HI-FLOW SUCTION CANISTER

    MDR report key: 1627336 · Received March 4, 2010

    Report

    Report Number
    2133713-2010-00001
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 4, 2010
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PROBABLE CAUSE OF FAILURE IS UV EMBRITTLEMENT OF PLASTIC. PRODUCT WAS MADE IN 2006, WHICH IS PRIOR TO IMPLEMENTATION OF EXPIRATION DATE (WHICH OCCURRED IN 2007).

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT TWO CANISTERS IMPLODED DURING ROUTINE TESTING OF VACUUM PUMPS THAT ARE LOCATED ON CODE CARTS. CANISTER WAS ORIGINAL EQUIPMENT SUPPLIED WITH PUMP. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY TO TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEMIS 1200CC HI-FLOW SUCTION CANISTER APPARATUS, SUCTION, VACUUM POWERED KDQ BEMIS MFG. CO. 480410 20060802

    Patients

    Seq Age Sex Outcome Treatment
    1