BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL CANNISTER KG 1600 CCE (10/CS)

    MDR report key: 3891438 · Received May 8, 2014

    Report

    Report Number
    3005515211-2014-00016
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 8, 2014
    Manufacturer
    AMSINO MEDICAL CO., LTD.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IT UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED TWO POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBERS ARE 31004 AND 31002. THE INTERNATIONAL AFFILIATE WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED. NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL INFORMATION KNOWN BY THE REPORTED UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO SUCTION. THE DEVICE WAS TO BE USED TO SUCTION UNSPECIFIED FLUIDS DURING AN UNSPECIFIED PROCEDURE. DURING TESTING OF THE DEVICE PRIOR TO PATIENT USE, IT WAS REPORTED THAT NO VACUUM COULD BE ESTABLISHED WITH 5 OR 6 DIFFERENT LINERS. IT WAS REPORTED THAT THE LIDS OF THE LINERS DID NOT FIT PROPERLY ONTO THE CANNISTER, WERE LOOSE, AND EASILY CAM OFF THE CANISTER AND LITTLE VACUUM WAS ESTABLISHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280162 RECEPTAL CANNISTER KG 1600 CCE (10/CS) 80GCX GCX AMSINO MEDICAL CO., LTD. NA PLOTSKY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SUCTION PUMP: MEGAMED 700, MFR UNK| RECEPTAL LINERS: LN OG904, LOT# 35200