BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX LUBRICATH

    MDR report key: 16486 · Received January 25, 1994

    Report

    Report Number
    16486
    Event Type
    Injury
    Date Received
    January 25, 1994
    Date of Event
    December 20, 1993
    Report Date
    December 29, 1993
    Manufacturer
    BARD UROLOGICAL
    Product Code
    FCN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO INSERT A URINARY DRAINAGE CATHETER IN ANESTHETIZED PATIENT PRIOR TO A SURGICAL PROCEDURE. THE RN SAID THAT THE CATHETER WAS INSERTED WITHOUT RESISTANCE. THERE WAS NO RETURN OF URINE, SO THE CATHETER WAS REMOVED. THE BALLOON HAD NOT BEEN INFLATED. THERE WAS SOME OOZING OF BLOOD FROM THE MEATUS AFTER THE CATHETER WAS REMOVED. A UROLOGIST WAS CONSULATED AND INSERTED A 16F CATHETER. PT RETURNED TO SURGERY 8 DAYS LATER FOR FULGURATION OF A BLEEDING PIT IN THE URETHRA. SURGICAL FINDINGS:FALSE PASSAGE RT BULBOUS URETHRA WITH BLEEDING. PT REPORTS NO PREVIOUS SYMPTOMS OF URINARY PROBLEMS.NO APPARENT PROBLEM WITH THE DEVICE WAS NOTED BY THE RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX LUBRICATH INDWELLING URINARY DRAINAGE CATHETER FCN BARD UROLOGICAL REORDER #892816

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization