BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ABSCESSION

    MDR report key: 1376148 · Received February 26, 2009

    Report

    Report Number
    1319211-2009-00007
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    January 23, 2009
    Report Date
    February 23, 2009
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GBX
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE LOT NUMBER WAS NOT REPORTED. A SHIP HISTORY WAS CONDUCTED ON THE REPORTED CATALOG NUMBER. THERE WAS ONLY ONE LOT SHIPPED TO THE COMPLAINANT 3 MONTHS BEFORE THE REPORTED INCIDENT DATE: (B) (4). THE POSSIBLE LOT NUMBER WAS REVIEWED FOR ANY ABNORMALITIES, WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING FOUND THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND THE FOLLOWING WAS OBSERVED: THE COMPLAINT SAMPLE WAS RETURNED IN TWO PIECES. THE FIRST SECTION IS THE HUB AND PART OF THE SHAFT. THIS SECTION IS 12CM IN LENGTH. THE SUTURE WIRE IS COILED AND KNOTTED AROUND THE SHAFT. THE DISTAL TIP OF THIS SECTION IS JAGGED. THE SECOND SECTION IS 12.5 CM OF THE DISTAL PORTION OF THE CATHETER. THE PROXIMAL END IS TORN AND JAGGED. THERE IS A 3CM JAGGED TEAR IN THE CATHETER SHAFT. THE SUTURE HOLES AT THE DISTAL TIP ARE TORN AND JAGGED. IT APPEARS AS IF THE SUTURE WIRE TORE THROUGH THE CATHETER SHAFT. CONCLUSION: THE COMPLAINT INVESTIGATION HAS BEEN CONFIRMED DURING THE VITAL INSPECTION OF THE RETURNED SAMPLE. THE COMPLAINT SAMPLE WAS RETURNED IN TWO PIECES. BASED ON THIS INFORMATION PROVIDED, IT APPEARS AS IF THE COMPLAINT IS USER RELATED. ALCOHOL WAS USED AND RAN THRU THE CATHETER TO SCLEROSES A CYST. THE LABELING AND INSTRUCTIONS FOR USE BOTH STATE THE FOLLOWING WARNING: "DO NOT USE THIS CATHETER WITH ALCOHOL". THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THE POSSIBLE LOTS WERE MANUFACTURED AND RELEASED TO SPECIFICATION. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    CATHETER BROKE IN HALF. ALCOHOL, HOWEVER, WAS USED AND RAN THRU THE CATHETER TO SCLEROSE A CYST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1