BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS

    MDR report key: 6463521 · Received April 6, 2017

    Report

    Report Number
    1317056-2017-00033
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Date of Event
    March 9, 2017
    Report Date
    April 6, 2017
    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 JANUARY 2017 (B)(4) COMPLAINT REPORT WAS REVIEWED FOR THE CONVENIENCE KIT PRODUCT FAMILY AND THE FAILURE MODE "DEVICE - AIR BUBBLES. " NO ADVERSE TREND WAS INDICATED. THE RETURNED COMPONENTS WERE RETURNED WITH THE CONTRAST INJECTION LINE (CIL) ATTACHED THE FEMALE LUER END PORT OF THE STOPCOCK, AS OPPOSED TO BEING ATTACHED TO THE ROTATING ADAPTOR, AS THE KIT IS PACKAGED. THE RETURNED CIL AND STOPCOCK WERE LEAK TESTED PRIOR TO BEING DISCONNECTED. THE SAMPLE PASSED THE LEAK TEST REQUIREMENTS PER (B)(4) PROCEDURES. THE STOPCOCK FEMALE TAPERS, AND FEMALE THREADS, AND MALE ROTATING ADAPTOR TAPER, AS WELL AS THE CIL FEMALE TAPER, FEMALE THREADS AND MALE TAPER WERE ALL MEASURED AND FOUND TO MEET SPECIFICATION. THE STOPCOCK AND THE CIL WERE INDEPENDENTLY LEAK TESTED AND EACH PASSED TESTING. THE REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED. THERE WERE NO MANUFACTURING RELATED DEFECTS NOTED TO THE RETURNED SAMPLES. THE SAMPLES WERE EVALUATED AND WERE FOUND VISUALLY, DIMENSIONAL AND FUNCTIONALLY ACCEPTABLE. THE END USER'S COMPLAINT DOES NOT APPEAR TO BE A MANUFACTURING RELATED ISSUE. A POSSIBLE ROOT CAUSE MAY BE THAT THE END USER DID NOT ADEQUATELY SECURE CONNECTIONS BETWEEN THE STOPCOCK/CIL OR THE DEVICE TO WHICH THEY WERE CONNECTING, OR THAT THE DEVICES NOT "FINGER TIGHTENED" PRIOR TO USE AS IT IS STATED IN THE DIRECTIONS FOR USE (DFU) PROVIDED TO THE CUSTOMER IN THE REPORTED KIT. THE DFU CONTAINS THE FOLLOWING STATEMENTS, "ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR THAT COULD RESULT IN EMBOLISM AND OR EXPOSURE TO BIOHAZARDS." (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY (B)(4), WHILE A HOSPITAL WAS UTILIZING A CONVENIENCE KIT COMPRISED OF A CONTRAST INJECTION LINE CONNECTED TO A STOPCOCK, "AIR ENTERED INTO THE DEVICE." THERE WAS NO REPORTED PATIENT INJURY AND THE USED DEVICE WAS RETURNED TO (B)(4) FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247721 ANGIODYNAMICS CONVENIENCE KIT OEZ ANGIODYNAMICS 4948681

    Patients

    Seq Age Sex Outcome Treatment
    1