BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 2000CC HI-FLOW SUCTION CATHETER

    MDR report key: 3038730 · Received March 12, 2013

    Report

    Report Number
    2133713-2013-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER (B)(4) CORRESPONDS TO LOT NUMBERS 20121025, 20121026, 20121029, 20121030.

    Description of Event or Problem · 1

    USER REPORTED THE BOTTOMS OF THREE CANISTERS "BLEW OUT" DURING THREE DIFFERENT ORTHOPEDIC PROCEDURES. THERE WAS NO PT INVOLVEMENT AND NO ONE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104382 BEMIS 2000CC HI-FLOW SUCTION CATHETER APPARATUS, VACUUM, SUCTION POWERED GCX BEMIS MFG. CO. 494410 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1