BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX 2 WAY

    MDR report key: 3893610 · Received June 9, 2014

    Report

    Report Number
    1018233-2014-00148
    Event Type
    Injury
    Date Received
    June 9, 2014
    Report Date
    May 16, 2014
    Manufacturer
    C.R. BARD, INC. (MONCKS)
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT VOIDED OUT BLOOD 30 MINUTES AFTER THE FOLEY CATHETER HAD BEEN REMOVED. UPON ASSESSMENT OF THE PATIENT, BLOOD WAS NOTED ON THE GOWN, AT THE URETHRAL OPENING, AND ON THE BED. A BLOOD CLOT WAS NOTED WHILE CLEANING THE PATIENT AND THE BEDDING. THE NURSE PRACTITIONER, UROLOGY AND CHARGE NURSE BROUGHT IN FOR ASSESSMENT. PATIENT DEVELOPED URINARY RETENTION AND PLACED ON FLOMAX. A SECOND CATHETER WAS PLACED SUCCESSFULLY. THE PATIENT WAS ABLE TO URINATE PRIOR TO DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334304 BARDEX 2 WAY EZC C.R. BARD, INC. (MONCKS) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention