BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SET

    MDR report key: 1023638 · Received March 31, 2008

    Report

    Report Number
    9616074-2008-00003
    Event Type
    Other
    Date Received
    March 31, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 29, 2008
    Manufacturer
    MEDISYSTEMS CORPORATION
    Product Code
    FJK
    PMA / PMN Number
    K983823
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS INCIDENT OF A CUT IN THE VENOUS TUBING. DUE TO POTENTIAL FOR CONTAMINATION THE PT'S BLOOD WAS NOT RETURNED RESULTING IN EBL = 100-200CC. NO PT INJURY OR NEED FOR MEDICAL INTERVENTION IS REPORTED. THIS MDR IS FILED FOR BLOOD LOSS ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SET HEMODIALYSIS BLOOD TUBING SET FJK MEDISYSTEMS CORPORATION NA 7075503

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other