BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ABSCESSION

    MDR report key: 1021946 · Received March 28, 2008

    Report

    Report Number
    1319211-2008-00010
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    December 19, 2007
    Report Date
    March 25, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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: 932459. 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 CATHETER WAS RETURNED IN THREE PIECES; THE PIGTAIL, THE HUB AND A 19CM CATHETER SHAFT. THE CATHETER TUBING IS DISCOLORED (DARK BLUE). THE HUB APPEARS TO HAVE BEEN CUT OFF OF THE CATHETER SHAFT. THE PIGTAIL HAS A JAGGED PROXIMAL END. THE CATHETER SHAFT HAS A CUT PROXIMAL END AND THE DISTAL END IS JAGGED AND MATCHES UP TO THE PROXIMAL END OF THE PIGTAIL. THE CATHETER SHAFT IS STIFF, NOT AS FLEXIBLE. CONCLUSION: THE COMPLAINT INVESTIGATION HAS BEEN CONFIRMED DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE. THE COMPLAINT SAMPLE WAS RETURNED IN THREE PIECES, THE TUBING IS DISCOLORED, THE TUBING IS STIFF NOT FLEXIBLE. ADDITIONAL INFORMATION WAS REQUESTED AND IT WAS REPORTED THE CATHETER WAS A GASTROSTOMY TUBE IN THE STOMACH AND HAD BEEN PLACED FOR APPROX FIVE WEEKS IN 2007. BASED ON THIS INFORMATION, IT APPEARS AS IF THE COMPLAINT IS USER RELATED. THE CATHETER WAS IN PLACE FOR THREE MONTHS AND WAS USED OFF LABEL AS A GASTROSTOMY TUBE IN THE STOMACH. THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THE POSSIBLE LOTS WERE MANUFACTURED AND RELEASED TO SPECIFICATION. THE FOLLOWING INFORMATION RELATED TO THIS COMPLAINT IS IN THE INSTRUCTIONS FOR USE: "WARNINGS: DO NOT USE THIS CATHETER AS A DELIVERY SYSTEM FOR NUTRITIONAL SUPPLEMENTS." "WHERE LONG-TERM USE IS INDICATED, IT IS RECOMMENDED THAT INDWELLING TIME NOT EXCEED 90 DAYS. THE PHYSICIAN SHOULD EVALUATE THE CATHETER ON OR BEFORE 90 DAYS POST-PLACEMENT." THE INDICATIONS FOR USE: 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. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    WHEN DOING PROCEDURE, NOTICED PIGTAIL END OF CATHETER WAS BROKE OFF.

    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 48 YR