BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL CANISTER 1000 ML CE

    MDR report key: 2601590 · Received May 25, 2012

    Report

    Report Number
    3005515211-2012-00003
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    April 1, 2012
    Report Date
    April 27, 2012
    Manufacturer
    AMSINO MEDICAL CO., LTD.
    Product Code
    GCX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE CATALOG # HAS A COMMON DEVICE NAME OF 80GCX AND HAS A 510K OF K831939. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO SUCTION. DURING TESTING USE AT THE USER FACILITY, IT WAS REPORTED THAT AFTER THE SUCTION LINER WAS INSERTED INTO THE DEVICE, THE LINER FIT "NOT FIRMLY, BUT LOOSELY" ON THE CANISTER AND "NO VACUUM IS CREATED." THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECEPTAL CANISTER 1000 ML CE UNK GCX AMSINO MEDICAL CO., LTD. NA 10003KY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA RECEPTAL LINER, LIST #UNK, LOT #UNK