BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER

    MDR report key: 6614 · Received September 20, 1993

    Report

    Report Number
    32574-1993-00004
    Event Type
    Malfunction
    Date Received
    September 20, 1993
    Date of Event
    June 30, 1993
    Report Date
    July 7, 1993
    Manufacturer
    BARD DAVOL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CENTER NOTIFIED REDLINE MEDICAL SUPPLY, INC. THAT WHILE A FOLEY CATHETER, WHICH WAS BEING USED AS A GASTROSTOMY TUBE, WAS BEING CHANGED ON A PATIENT, THE BALLOON PORTION OF THE CATHETER DID NOT PROPERLY DEFLATE. APHYSICIAN WAS IN THE FACILITY AND ASSISTED BY CUTTING OFF THE TIP OF THE "Y" SECTION OF THE CATHETER AND PULLED THE CATHETER UP AND POKED IT RELEASING THE WATER. THE PATIENT WAS NOT INJURED AND IS FINE. THE NURSING HOME REPOERTED THAT THE CATHETER INVOLVED IN THIS INCIDENT WAS MANUFACTURERED BY BARD DAVOL. BARD DAVOL HAS BEEN NOTIFIED OF THIS INCIDENT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT 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.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER KOD BARD DAVOL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other