BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ABSCESSION DRAINAGE CATHETER

    MDR report key: 2151368 · Received June 8, 2011

    Report

    Report Number
    1319211-2011-00054
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    April 29, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GBX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS ONE USED DRAINAGE CATHETER 12F X 30CM. VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT IT WAS BROKEN INTO FOUR PIECES RANGING IN LENGTH FROM APPROX 1CM TO APPROX 6CM. THE COMPLAINT IS CONFIRMED. THE OD OF THE TUBE ON THREE OF THE RETURNED PIECES MEASURED TO BE WITHIN SPECIFICATIONS. THE CONDITION OF THE FOURTH PIECE OF RETURNED CATHETER PREVENTED AN ACCURATE MEASUREMENT OF THE OD. THE ID OF THE TUBE ON THE THREE OF THE RETURNED PIECES MEASURED TO BE WITHIN SPECIFICATIONS. THE CONDITION OF THE FOURTH PIECE OF RETURNED CATHETER PREVENTED AN ACCURATE MEASUREMENT OF THE OD AND ID OF THE TUBE. ALTHOUGH THE COMPLAINT IS CONFIRMED THE EXACT ROOT CAUSE CANNOT BE DETERMINED. DIMENSIONAL CHECKS OF THREE OF THE RETURNED PIECES NOTED THAT THEY MET SPECIFICATIONS FOR OD AND ID. THE MOST LIKELY ROOT CAUSE FOR THE REPORTED COMPLAINT IS THAT THE DRAINAGES CATHETER SHAFT WAS INCOMPATIBLE WITH PROCEDURAL FLUIDS USED; HOWEVER THIS CANNOT BE DEFINITIVELY DETERMINED AT THIS TIME. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER, CONTAINS A STATEMENT "THE CATHETERS ARE DESIGNED FOR PERCUTANEOUS DRAINAGE OF FLUIDS. 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 MET ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS PRODUCT FAMILY AND COMPLAINT TYPE. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER ON (B)(6) 2011, PHYSICIAN WAS ASKED TO CHECK ON THE DRAINAGE CATHETER FOR A POTENTIAL LEAK. IMAGING OF THE DEVICE NOTED THAT THE CATHETER HAD FRACTURED IN THE PT. TWO SNARE ATTEMPTS WERE CONDUCTED ((B)(6) 2011). THESE ATTEMPTS WERE UNSUCCESSFUL. THE CATHETER FRAGMENTS WERE SUCCESSFULLY REMOVED SURGICALLY FROM THE PT ON (B)(6) 2011. ANOTHER DRAIN FROM A DIFFERENT MANUFACTURER WAS PLACED ON (B)(6) 2011. THERE WAS NO HARM OR INJURY REPORTED TO THE PT AND AS OF (B)(6) 2011 THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ABSCESSION DRAINAGE CATHETER DRAINAGE CATHETER GBX ANGIODYNAMICS NA NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention