BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD FOLEY CATHETER MODEL 18 FR

    MDR report key: 21060 · Received March 7, 1995

    Report

    Report Number
    21060
    Event Type
    Malfunction
    Date Received
    March 7, 1995
    Date of Event
    March 22, 1994
    Report Date
    February 17, 1995
    Manufacturer
    BARD UROLOGICAL DIVISION (C.R. BARD INC.)
    Product Code
    EYJ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON MARCH 22, 1994, A PATIENT WAS ADMITTED TO THE HOSPITAL FOR EVALUATION OF CHEST PAIN. THE PATIENT WAS ADMITTED WITH A FOLEY CATHETER, AND THE NEXT MORNING THE NURSING STAFF CHANGED THE CATHETER BECAUSE OF SEDIMENT IN THE URINE. UPON REMOVAL OF THE CATHETER, THE BALLOON APPEARED NOT TO BE INTACT, AND THERE WERE VERY SMALL PIECES OF WHAT APPEARED TO BE LATEX AT THE URETHRAL OPENING. THE CATHETER WAS RETURNED TO THE MANUFACTURER.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FOLEY CATHETER MODEL 18 FR EYJ BARD UROLOGICAL DIVISION (C.R. BARD INC.) MODEL 18 FR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other