BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDCOMP HEMO FLOW PRE CURVE

    MDR report key: 10419822 · Received August 17, 2020

    Report

    Report Number
    MW5096104
    Event Type
    Injury
    Date Received
    August 17, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 14, 2020
    Manufacturer
    MEDICAL COMPONENTS INC DBA MEDCOMP
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RECEIVING DIALYSIS AT BEDSIDE. DIALYSIS RN NOTICED BLEEDING FROM THE BLUE PORT. WHEN SEEN THE PLASTIC PART NEAR THE BLUE PORT WAS OPEN - DEFECTIVE DEVICE. PERM CATH WAS THEN REMOVED PER DR ORDERS. THE TIP OF THE CATHETER WAS SENT FOR CULTURE. DRESSING APPLIED TO RIGHT CHEST-NO FURTHER BLEEDING. NONEMERGENT DIALYSIS-VAS CATH SCHEDULED FOR AM AND PATIENT WILL RECEIVE DIALYSIS IN AM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877926 MEDCOMP HEMO FLOW PRE CURVE CATHETER, HEMODIALYSIS, IMPLANTED MSD MEDICAL COMPONENTS INC DBA MEDCOMP MC641522 MNWA610

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention