BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ABSCESSION DRAINAGE CATHETER

    MDR report key: 1864597 · Received October 5, 2010

    Report

    Report Number
    1319211-2010-00039
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS ONE USED DRAINAGE CATHETER. A VISUAL EXAMINATION OF THE DEVICE NOTED THAT CATHETER WAS BROKEN IN TWO, APPROX 25 CM FROM THE PIGTAIL. THE APPROX 5 CM OF CATHETER ATTACHED THE LUER WAS NOT RETURNED, AS IT WAS DISPOSED OF BY THE END USER. THE COMPLAINT IS CONFIRMED. THE MOST LIKELY ROOT CAUSE FOR THE REPORTED COMPLAINT TYPE IS THAT CATHETER WAS INCOMPATIBLE WITH PROCEDURAL FLUIDS; HOWEVER, THIS CANNOT BE DEFINITIVELY DETERMINED. THE INSTRUCTIONS FOR USE ((B)(4)), WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER, CONTAINS A STATEMENT, "THE CATHETERS ARE DESIGNED FOR PERCUTANEOUS DRAINAGE OF FLUIDS. THIS DEVICE IS NOT INDICATED FOR DIRECT CONTACT WITH THE HEART, CENTRAL CIRCULATORY SYSTEM OR THE CENTRAL NERVOUS SYSTEM. WARNINGS: DO NOT USE THIS CATHETER WITH ALCOHOL. DO NOT USE THIS CATHETER AS A DELIVERY SYSTEM FOR NUTRITIONAL SUPPLEMENTS." DURING THE REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT THAT WAS OBTAINED THROUGH A SHIP HISTORY REVIEW, IT WAS OBSERVED THAT THE MANUFACTURED LOT MEETS ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED THIS IS THE FIRST REPORTED COMPLAINT FOR THIS PRODUCT FAMILY AND COMPLAINT TYPE IN FIVE YEARS. NO TRENDS WERE NOTED FOR THIS PRODUCT FAMILY AND COMPLAINT TYPE. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. COMPLAINT (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER, "AFTER PLACEMENT THIS CATHETER HAD BROKEN INTO TWO PIECES." THE DETACHED PORTION OF CATHETER WAS EASILY REMOVED FROM PT AS THE CATHETER BROKE OUTSIDE THE PT. THE DEVICE WAS REPLACED WITH ANOTHER NEW OF THE SAME DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO HARM TO THE PT DUE TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ABSCESSION DRAINAGE CATHETER DRAINAGE CATHETER DQY ANGIODYNAMICS, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1