BEUDAMED
    FDA Adverse Event Other Summary report: N

    4273505

    MDR report key: 476047 · Received August 1, 2003

    Report

    Report Number
    1718873-2003-00002
    Event Type
    Other
    Date Received
    August 1, 2003
    Date of Event
    July 2, 2003
    Report Date
    August 1, 2003
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER TUBE WAS SEVERED AT THE BIFURCATION HUB. AN RN NOTICED THE SEVERED CATHETER WHILE CHECKING THE PT. THE RN WAS NOT SURE HOW LONG THE CATHETER HAD BEEN SEVERED, BUT DIDN'T THINK MUCH TIME HAD LAPSED. THE HOSP REPORTED THAT THERE WAS "MINIMAL" BLOOD LOSS, AND NO TREATMENT WAS REQUIRED AS A RESULT OF THE BREAK. THE MANAGER STATED THAT THE PT WAS NOT INTUBATED, SO HOSP PROTOCOL IS TO ASSESS THE PT EVERY 2 HRS. THERE IS A CLINICIAN IN THE AREA AT ALL TIMES, AND NO ALARMS SOUNDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4273505 UMBILICAL CATHETER FOS UTAH MEDICAL PRODUCTS, INC. NA 130200-1

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other