BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS

    MDR report key: 5641113 · Received May 9, 2016

    Report

    Report Number
    1317056-2016-00017
    Event Type
    Malfunction
    Date Received
    May 9, 2016
    Date of Event
    January 21, 2016
    Report Date
    January 25, 2016
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OEZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE (B)(6) 2015 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE CONVENIENCE KIT PRODUCT FAMILY AND THE FAILURE MODE "AIR BUBBLES NOTED." NO ADVERSE TREND WAS IDENTIFIED. USED STOPCOCKS WITH CONTRAST INJECTION LINES ATTACHED WERE RETURNED FOR EVALUATION, AS WELL AS A USED INFLATION DEVICE OF UNKNOWN ORIGIN. NO MANUFACTURING NON-CONFORMANCES WERE VISIBLE ON THE DEVICES. THE CONNECTION SITES BETWEEN THE STOPCOCKS AND CILS APPEARED TO BE FIRMLY ATTACHED, BUT NOT OVER-TIGHTENED. UNDER MAGNIFICATION, NO CRACKED FITTINGS OR OTHER DAMAGE WAS OBSERVED. THE SAMPLES WERE AIR LEAK TESTED, AND PASSED. ALL FITTINGS ON THE STOPCOCKS AND CILS WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE SAMPLES WERE THEN PRIMED AND ATTACHED TO THE MALE FITTING OF THE INFLATION DEVICE. PRESSURE WAS APPLIED BY HAND, AND NO LEAKS WERE NOTED AT ANY CONNECTION SITES. NO DIFFICULTY WAS ENCOUNTERED WHEN CONNECTING THE STOPCOCKS TO THE INFLATION DEVICE. THE REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED. THE SAMPLES WERE EVALUATED AND WERE FOUND VISUALLY, DIMENSIONAL AND FUNCTIONALLY ACCEPTABLE, AND THE COMPLAINT DOES NOT APPEAR TO BE A MANUFACTURING RELATED ISSUE. POSSIBLE ROOT CAUSE MAY BE THAT THE END USER DID NOT ADEQUATELY SECURE CONNECTIONS BETWEEN THE STOPCOCK AND THE CIL OR THE INFLATION DEVICE THEY WERE CONNECTING TO, OR THE CONNECTIONS WERE NOT "FINGER TIGHTENED" PRIOR TO USE AS IT IS STATED IN THE DFU PROVIDED TO THE CUSTOMER IN THE REPORTED KIT. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), WHILE UTILIZING A CONVENIENCE KIT, THE END USER PHYSICIAN OBSERVED AIR ENTERING THE SYSTEM. BELIEVED TO BE A RESULT OF THE CONNECTION BETWEEN THE STOPCOCK IN THE KIT AND THE INFLATION DEVICE (NOT PROVIDED BY ANGIODYNAMICS) CONNECTOR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295399 ANGIODYNAMICS CONVENIENCE KIT OEZ ANGIODYNAMICS 4807848

    Patients

    Seq Age Sex Outcome Treatment
    1