BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 REC CANISTER

    MDR report key: 3963578 · Received April 10, 2014

    Report

    Report Number
    3005515211-2014-00015
    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
    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

    GENERAL REPORT OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS WAS RECEIVED FOR CRACKED CANISTERS; SUBSEQUENTLY, A LOSS OF SUCTION WAS NOTED. AT UNSPECIFIED TIMES THE DEVICES WERE TO BE USED FOR UNSPECIFIED PROCEDURES. IT WAS REPORTED THAT PRIOR TO PATIENT USE WHEN THE VACUUMS WERE STARTED, THE SUCTION LINERS DID NOT EXPAND. DURING VISUAL EXAMINATION AT THE USER FACILITY, CRACKS ON THE T-SIDE OF THE CANISTERS WERE NOTED. THE CANISTERS WERE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216601 21 REC CANISTER 80GCX GCX AMSINO MEDICAL CO., LTD NA UNKKY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA UNSPECIFIED RECEPTAL SUNCTION LINERS, LIST #UNK,| LOT #UNK