BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    42 ML CAN SAF

    MDR report key: 4232457 · Received September 24, 2014

    Report

    Report Number
    3005515211-2014-00018
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 4, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO SUCTION. THE SUCTION CANISTER WAS TO BE USED TO SUCTION GASTRIC CONTENTS VIA AN UNSPECIFIED NASOGASTRIC TUBE (NG). THE CUSTOMER CONTACT REPORTED THAT WHEN THE NURSES HOOKED UP THE SUCTION CANISTER, NO SUCTION WAS NOTED. IT WAS REPORTED THAT A WHITE PIECE ON THE UNDERSIDE OF THE LID OF THE CANISTER WAS NOTED. THE CUSTOMER CONTACT REPORTED THAT WHEN THE WHITE PIECE WAS REMOVED, 300 ML OF GASTRIC CONTENTS WERE IMMEDIATELY SUCTIONED, VIA NG. NO SPECIFIC DETAILS WERE PROVIDED. IT WAS REPORTED THAT PRIOR TO THE SUCTION WORKING, THE PATIENT EXPERIENCED NAUSEA. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO A PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED INCLUDING THE USAGE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593280 42 ML CAN SAF 80GCX GCX AMSINO MEDICAL CO., LTD. (CONTRACT MANUFACTURER FOR HOSPIRA, INC.) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK