BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURP CBI TUBING

    MDR report key: 8546699 · Received April 23, 2019

    Report

    Report Number
    MW5086143
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 17, 2019
    Report Date
    April 19, 2019
    Manufacturer
    UNK
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CBI TUBING WAS BEING UTILIZED ON PATIENT. TIP ON TUBING SPIKE BROKE OFF AND UNABLE TO BE LOCATED. POSSIBLY ENTERED BLADDER AND CONCERNS FOR RETAINED FOREIGN OBJECT. PATIENT IS CRITICALLY ILL AT THIS TIME AND NO TEST ARE SCHEDULED DUE TO OTHER MEDICAL ISSUES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335815 TURP CBI TUBING CATHETER, UROLOGICAL KOD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR