BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F X 18CM HEMO-CATH

    MDR report key: 8785000 · Received July 12, 2019

    Report

    Report Number
    2518902-2019-00041
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 12, 2019
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    UDI-DI
    00884908045444
    PMA / PMN Number
    K893439
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVALUATION. A RECORD AND DHR REVIEW CANNOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. WITHOUT A PHYSICAL EVALUATION OF THE DEVICE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE RED AND BLUE LUERS ON THE END OF THE EXTENSION LINES WERE NOTED TO BE LOOSE AT THE POINT OF DISCONNECTION FROM THE DIALYSIS TREATMENT. THE NURSES WERE ABLE TO ROTATE THE HUB IN THE SLEEVE AND IT WAS VISIBLY LOOSE. ALCOHOL PREP PADS ARE USED TO CLEANSE THE LINES, USING A TOTAL OF ABOUT 8-10 PREP PADS DURING THE CONNECTION AND DISCONNECTION PROCESS. MORE PADS ARE USED IF THE PATIENT'S LINE HAS TO BE REVERSED AT ANY POINT DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577427 8F X 18CM HEMO-CATH HEMO-CATH LT MSD MEDCOMP SL18P UNK 00884908045444

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR