BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 800CC HYDROPHOBIC SUCTION CANISTER

    MDR report key: 3938595 · Received March 6, 2014

    Report

    Report Number
    2133713-2014-00008
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 24, 2014
    Report Date
    March 4, 2014
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER REPORTED ((B)(4)) CORRESPONDS TO LOT NUMBERS 20130924, 20130925, 20130926, AND 20130927. THERE WAS ONLY A PARTIAL CARTON OF LOT 20130925 IN THE PARTS DEPARTMENT. THESE WERE EXAMINED FOR CRACKING, AND TESTED AT MAXIMUM AVAILABLE VACUUM (25IN HG.). THERE WERE NO FAILURES. WE CANNOT DETERMINE CAUSE. WE WILL UPDATE THIS REPORT IF MORE INFO IS FORTHCOMING FROM THE COMPLAINANT.

    Description of Event or Problem · 1

    REPORTED STATED THAT IN A HOME CARE SITUATION, USER EXPERIENCED 5 OUT OF SIX LIDS CRACK AS SOON AS VACUUM WAS APPLIED. THERE WAS NO PATIENT INVOLVEMENT, AND NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134367 BEMIS 800CC HYDROPHOBIC SUCTION CANISTER BOTTLE, COLLECTION, VACUUM KDQ BEMIS MFG. CO. 424410 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1