BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 3963992 · Received May 8, 2014

    Report

    Report Number
    8030665-2014-00362
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    REYNOSA PLANT
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT A NURSE PUT A SYRINGE ON "PIGTAIL" OF VENOUS DROP CHAMBER AND BLOOD SPRAYED FROM THAT CONNECTION. THE MACHINE HAD A VENOUS PRESSURE ALARM. ESTIMATE BLOOD LOSS WAS 20 TO 30 CC'S. PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS ABLE TO COMPLETE TREATMENT. SAMPLE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278009 CUSTOM COMBI SET FJK REYNOSA PLANT

    Patients

    Seq Age Sex Outcome Treatment
    1