BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH PRESSURE/CRYSTALINE CONNECTING LINES

    MDR report key: 2123531 · Received June 9, 2011

    Report

    Report Number
    1319211-2011-00055
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DXT
    PMA / PMN Number
    K890208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # 526895. RETURNED FOR EVAL WERE 59 UNUSED, UNOPENED 72" HP LINES (30 OF LOT 526895 AND 29 OF 529075.) LOT 526895 HAS A MFG DATE OF 09/2010 AND AN EXPIRATION DATE OF 09/30/2013. LOT 529075 HAS A MFG DATE OF 11/2013 AND AN EXPIRATION DATE OF 11/30/2013. A VISUAL REVIEW OF THE DEVICES NOTED NO DEFECTS. A DEVICE WAS REMOVED FROM THE POUCH. A VISUAL REVIEW OF THE ROTATING ADAPTOR AND THE FEMALE LUER LOCK UNDER MICROSCOPE NOTED NO DEFECTS. A 10CC SYRINGE WAS OBTAINED FROM STOCK AND PRIMED WITH WATER. THE SYRINGE WAS THEN CONNECTED TO THE FEMALE LUER OF THE 72" HP LINE. A THREE WAY STOPCOCK WAS OBTAINED FROM STOCK AND CONNECTED TO THE ROTATING ADAPTOR OF THE 72" HP LINE. THE 72" LINE WAS THEN FLUSHED WITH WATER. THE 72" HP LINE WAS SUCCESSFULLY DE-BUBBLED. THIS PROCESS WAS REPEATED FIVE TIMES. EACH TIME THE 72" HP LINE WAS SUCCESSFULLY DE-BUBBLED. THE COMPLAINT COULD NOT BE CONFIRMED AS THE RETURNED DEVICE FUNCTIONED AS INTENDED. THE MOST LIKELY ROOT CAUSE FOR THE REPORTED COMPLAINT IS THAT THE END USER EITHER OVER TIGHTENED THE CONNECTIONS CAUSING CRACKS IN THE LUER OR THE CONNECTIONS WERE NOT TIGHT ENOUGH CAUSING BUBBLES IN THE LINE. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS PRODUCT FAMILY AND COMPLAINT TYPE. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER, THEY EXPERIENCED PROBLEMS WITH AIR BUBBLES IN THE 72" HIGH PRESSURE CONNECTION LINE. AIR WAS NOT INJECTED INTO THE PT. THE END USER SWITCHED FROM A ROTATING ADAPTOR 72" HIGH PRESSURE CONNECTION LINE TO A FIX LUER 72" HIGH PRESSURE CONNECTION LINE AND COMPLETED THE CASE WITHOUT FURTHER COMPLICATIONS. NO HARM OR INJURY WAS REPORTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH PRESSURE/CRYSTALINE CONNECTING LINES CONNECTING LINES DXT ANGIODYNAMICS NA 529075

    Patients

    Seq Age Sex Outcome Treatment
    1