BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL CANISTER 1000 ML CE

    MDR report key: 2852195 · Received November 12, 2012

    Report

    Report Number
    3005515211-2012-00116
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    AMSINO MEDICAL CO., LTD
    Product Code
    GCX
    PMA / PMN Number
    K831939
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 INCOMING INSPECTION PRIOR TO CLINICAL USE, IT WAS REPORTED THAT AFTER THE SUCTION LINER WAS INSERTED INTO THE DEVICE, NO SUCTION WAS CREATED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECEPTAL CANISTER 1000 ML CE 80GCX GCX AMSINO MEDICAL CO., LTD NA 13007KY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA RECEPTAL LINER: LIST #0L212, LOT #12215KZ