BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAC-GARD LINER 2000 ML

    MDR report key: 4232442 · Received September 29, 2014

    Report

    Report Number
    3005515211-2014-00019
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    July 31, 2014
    Report Date
    September 11, 2014
    Manufacturer
    AMSINO MEDICAL CO., LTD.: CONTRACT MANUFACTURER FOR HOSPIRA INC.
    Product Code
    GCX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTED UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT GENERATE SUCTION. THE SUCTION LINER WAS BEING USED TO SUCTION THE PATIENT'S SECRETIONS. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE DEVICE DID NOT GENERATE SUCTION OF THE PATIENT'S SECRETIONS. THE CUSTOMER CONTACT INDICATED THAT IT WAS NOTED THAT THE FILTER WAS WET. THE DEVICE WAS REPLACED. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604196 VAC-GARD LINER 2000 ML 80GCX GCX AMSINO MEDICAL CO., LTD.: CONTRACT MANUFACTURER FOR HOSPIRA INC. NA 35022KY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED SUCTION CANISTER, MFR: UNK