BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 1200CC HIFLOW SUCTION CANISTER

    MDR report key: 1673078 · Received April 30, 2010

    Report

    Report Number
    2133713-2010-00002
    Event Type
    Malfunction
    Date Received
    April 30, 2010
    Date of Event
    April 15, 2010
    Report Date
    April 29, 2010
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PROVIDED SERIAL NUMBER (B)(4) FROM THE FAILED PRODUCT. SERIAL NUMBER CORRESPONDS TO (B)(4), 2003 PRODUCTION. LIKELY CAUSE OF IMPLOSION IS EMBRITTLEMENT OF PLASTIC DUE TO EXCESSIVE UV EXPOSURE. SINCE 2007 THIS PRODUCT BEARS A 3 YEAR EXPIRATION PERIOD.

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT DURING A SAFETY INSPECTION, A SUCTION CANISTER ON A CODE CART IMPLODED. ONE OF THE EMPLOYEES PRESENT COMPLAINED OF "HEADACHE, RINGING EARS, AND TEARY EYES." THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEMIS 1200CC HIFLOW SUCTION CANISTER APPARATUS, SUCTION, VACUUM POWERED KDQ BEMIS MFG. CO. 480410 20030107

    Patients

    Seq Age Sex Outcome Treatment
    1