BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUBCUTANEOUS PORT TUBING

    MDR report key: 7922 · Received March 7, 1994

    Report

    Report Number
    7922
    Event Type
    Malfunction
    Date Received
    March 7, 1994
    Date of Event
    September 15, 1993
    Report Date
    December 29, 1993
    Manufacturer
    NORFOLK MEDICAL PRODUCTS, INC.
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TUBING FROM SUBCUTANEOUS PORT SHEARED OFF AND MIGRATED INTO VASCULAR SYSTEM (HEART). TURING REMOVED BY CARDIOLOGIST AT AN EARLIER DATE. REMAINDER OF MEDIPORT REMOVED ON SEPTEMBER 15, 1993INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE INDIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUBCUTANEOUS PORT TUBING NORFOLK MEDICAL PRODUCTS, INC. NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other