BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIPRO SAFETOUCH II SAFETY AVF NEEDLE

    MDR report key: 2582723 · Received May 17, 2012

    Report

    Report Number
    8041145-2012-00002
    Event Type
    Death
    Date Received
    May 17, 2012
    Date of Event
    April 6, 2012
    Report Date
    May 3, 2012
    Manufacturer
    NIPRO THAILAND CORPORATION LTD.
    Product Code
    FMI
    PMA / PMN Number
    K032777
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. IT WAS DISCARDED AT THE FACILITY. BIOLOGICAL TESTS PERFORMED ON DEVICES FROM THE SAME LOT OF PRODUCT. ALL RESULTS REPORTED WITHIN PARAMETERS. SEE REPORT FOR DETAILS. THE DEVICE PERFORMED ACCORDING THE SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT DONATED PLASMA (B)(6) 2012. HE SUFFERED A NON-VIOLENT, AS-YET UNEXPLAINED DEATH ON (B)(6) 2012. WE ARE AWAITING THE MEDICAL EXAMINER REPORT. THE DEATH WAS REPORT TO THE PLASMA CENTER (B)(6) 2012 AND THEY STARTED THE NOTIFICATION AND INVESTIGATION PROCESS. THE CUSTOMER HAD A SUCCESSFUL PLASMAPHERESIS DONATION ON (B)(6) 2012. THERE WERE NO INCIDENTS OR REACTIONS AND THE CUSTOMER LEFT THE FACILITY WITHOUT INCIDENT. THE PATIENT USED A 16G NIPRO SAFETOUCH II SAFETY FISTULA NEEDLE FOR HIS PLASMAPHERESIS. IT WORKED AS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO SAFETOUCH II SAFETY AVF NEEDLE SAFETY FISTULA NEEDLE FMI NIPRO THAILAND CORPORATION LTD. FS+163230BC 11I15

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death