BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FOLEY TRAY

    MDR report key: 93950 · Received May 23, 1997

    Report

    Report Number
    93950
    Event Type
    Injury
    Date Received
    May 23, 1997
    Date of Event
    May 8, 1997
    Report Date
    May 23, 1997
    Manufacturer
    BARD UROLOGICAL DIVISION., C.R. BARD, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    R.N. ATTEMPTED TO CATHETERIZE PT WITH BARD FOLEY TRAY, #16 FR. SHE MET RESISTANCE AND WAS UNABLE TO ADVANCE CATHETER. ON REMOVAL, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS MISSING, HAVING BROKEN OFF THROUGH THE EYE. THE TIP OF THE CATHETER WAS NOT FOUND. ON MAY 12, 1997 PT UNDERWENT CYSTOSCOPY FOR REMOVAL OF FOREIGN BODY. TIP OF CATHETER WAS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FOLEY TRAY UROLOGICAL CATHETER KOD BARD UROLOGICAL DIVISION., C.R. BARD, INC. NA 76JG2571

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention