BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ABSCESSION DRAINAGE CATHETER

    MDR report key: 949894 · Received November 14, 2007

    Report

    Report Number
    1319211-2007-00036
    Event Type
    Malfunction
    Date Received
    November 14, 2007
    Date of Event
    October 16, 2007
    Report Date
    November 7, 2007
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE LOT NUMBER WAS NOT PROVIDED. A SHIP HISTORY WAS CONDUCTED AND SHOWED THE FOLLOWING LOTS HAD BEEN SHIPPED TO THE COMPLAINANT: 924827, 929060, 930986, 934831, 934832, AND 934840. THE POSSIBLE LOT NUMBERS WERE 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 CATHETER RETURNED IS 27CM IN LENGTH. APPROX 2 CM OF THE CATHETER IS MISSING. THE TIP IS BROKEN OFF. THE BREAK IS AT ONE OF THE DRILL HOLES. THE BREAK IS JAGGED. THE BREAK IS NOT AT THE SUTURE WIRE HOLE. THE CATHETER IS NOT DISCOLORED. THE CATHETER SHAFT MATERIAL IS FLEXIBLE. CONCLUSION: THE COMPLAINANT INVESTIGATION HAS BEEN CONFIRMED DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE. DURING THE EVALUATION OF THE RETURNED SAMPLE, IT WAS CLEAR THE TIP HAD BROKE OFF. BASED ON THE INFO PROVIDED, IT APPEARS AS IF THE CATHETER BREAK WAS CAUSED FROM THE PATIENT PULLING OUT THE CATHETER. PULLING OUT A CATHETER WITH A LOCKED PIGTAIL CAN LEAD TO A CATHETER BREAK. THE TOTAL ABSCESSION DRAINAGE CATHETER IS DESIGNED FOR PERCUTANEOUS DRAINAGE OF FLUIDS AND IS NOT INDICATED FOR DIRECT CONTACT WITH THE HEART, CENTRAL CIRCULATORY SYSTEM OR THE CENTRAL NERVOUS SYSTEM. THE REVIEW OF THE MFG RECORDS VERIFIED THE POSSIBLE LOTS WERE MANUFACTURED AND RELEASED TO SPECIFICATION. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING INDICATIONS TO HELP AVOID THIS COMPLAINT TYPE FROM OCCURRING: "WARNINGS: DO NOT USE THIS CATHETER AS A DELIVERY SYSTEM FOR NUTRITIONAL SUPPLEMENTS.", "DO NOT USE THIS CATHETER WITH ALCOHOL.", "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." 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 NO GREATER THAN USUAL.

    Description of Event or Problem · 1

    PATIENT PULLED OUT TUBE AND THE CATHETER BROKE OFF AT PIGTAIL. THE FACT THE CATHETER BROKE IS ALARMING TO THE MD'S AND NURSES BECAUSE THE PATIENTS PULL OUT TUBES ALL THE TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR