BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 REC CANISTER

    MDR report key: 3963558 · Received April 10, 2014

    Report

    Report Number
    3005515211-2014-00007
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    AMSINO MEDICAL CO., LTD
    Product Code
    GCX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICES WERE DISCARDED. INVESTIGATION IS NOT COMPLETE. 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 A CRACKED CANISTER; SUBSEQUENTLY, A LOSS OF SUCTION WAS NOTED. AT AN UNSPECIFIED TIME, THE DEVICE WAS TO BE USED FOR AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT PRIOR TO PATIENT USE WHEN THE VACUUM WAS STARTED, THE SUCTION LINER DID NOT EXPAND. DURING VISUAL EXAMINATION AT THE USER FACILITY, CRACKS ON THE T-SIDE OF THE CANISTER WERE NOTED. THE CANISTER WAS REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216598 21 REC CANISTER 80GCX GCX AMSINO MEDICAL CO., LTD NA UNKKY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED RECEPTAL SUCTION LINER, LIST #UNK,| LOT # UNK