BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 320 · Received March 2, 1992

    Report

    Report Number
    320
    Event Type
    Malfunction
    Date Received
    March 2, 1992
    Date of Event
    February 6, 1992
    Report Date
    February 17, 1992
    Manufacturer
    N/A
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    BROVIAC TUBE NOTED TO BE LEAKING. CLAMP USED PROPERLY AND TUBING WAS CLAMPED IN PROPER AREA OF TUBE.-CAUSE OF TUBE BREAKING IS UNKNOWN. NO ADVERSE EVENT TO PATIENT OCCURRED. PATIENT TRANSFERRED TO HOSPITAL FOR REPAIR OF BROVIAC TUBING. RETURNED WITHIN HOURS WITH REPAIRED CATHETERINVALID 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. DEVICE WAS EVALUATED AFTER THE 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 UNKNOWN BROVIAC CATHETER DQR N/A UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Other