BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS

    MDR report key: 7169713 · Received January 5, 2018

    Report

    Report Number
    1317056-2018-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    October 31, 2017
    Report Date
    February 16, 2018
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OEZ
    UDI-DI
    H7496566087241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED FOR THE 3 REPORTED KIT PACKAGING LOTS AND THEIR 9 ASSOCIATED CONTRAST CONTROLLER ASSEMBLY LOTS. NO ADDITIONAL COMPLAINTS OR INTERNAL NON-CONFORMANCE REPORTS WERE ASSOCIATED WITH ANY OF THE LOTS. THE RECENT ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE CONVENIENCE KIT PRODUCT FAMILY AND THE FAILURE MODE "DEVICE - AIR BUBBLES. " NO ADVERSE TREND WAS IDENTIFIED. THE REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED, NOR CAN A DEFINITIVE ROOT CAUSE BE DETERMINED, AS NO SAMPLE WAS RETURNED TO ANGIODYNAMICS. (B)(4) (THE DISTRIBUTOR) PERFORMED INITIAL TESTING ON THE COMPLAINT SAMPLES AND OBSERVED WHAT THEY CONSIDERED TO BE NON-NORMAL FLOW OF CONTRAST INTO THE CHAMBER AS A RESULT OF EXCESS FORCE NEEDED TO ASPIRATE. THE POTENTIAL ROOT CAUSE OF THE FLOW PROBLEM IS A BONDING OR COMPONENT ISSUE PROXIMAL TO THE CC CHAMBER, BUT THIS CANNOT BE DEFINITIVELY DETERMINED WITHOUT SAMPLE EVALUATION BY ANGIODYNAMICS. THE SAMPLES FORWARDED TO ANGIODYNAMICS FROM THE DISTRIBUTOR WERE LOST IN TRANSIT. ANGIODYNAMICS' MANUFACTURING PROCESS CONTROLS FOR THE CONTRAST CONTROLLER DEVICE INCLUDE VISUAL INSPECTION FOR MOLDING NON-CONFORMITIES, IN-PROCESS INSPECTION LEAK TESTING, AND DIMENSIONAL VERIFICATION. THE DIRECTIONS FOR USE PROVIDED WITH THE DEVICE INCLUDE THE FOLLOWING INSTRUCTIONS: "ENSURE THAT YOU ARE MAKING SECURE CONNECTIONS WHEN USING THIS DEVICE TO PREVENT THE INTRODUCTION OF AIR INTO THE SYSTEM THAT COULD RESULT IN EMBOLISM AND IN RARE INSTANCES OF DEATH. 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. EXAMINE PRODUCT CAREFULLY FOR ENTRAPPED AIR AND FULLY DEBUBBLE PRIOR TO INJECTION TO MINIMIZE THE POTENTIAL FOR EMBOLISM AND IN RARE INSTANCES DEATH." (B)(4).

    Additional Manufacturer Narrative · 1

    IT HAS BEEN INDICATED THAT THE SAMPLES FROM THE REPORTED EVENT WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION, BUT THEY HAVE NOT YET ARRIVED. UPON RECEIPT OF THE SAMPLES AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), HOSPITAL USING AN ANGIODYNAMICS KIT PROVIDED IN A (B)(6) PROCEDURE PACK REPORTED AIR BUBBLES IN THE CONTRAST LINE, POST FLUSHING OF THE LINE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE USED SAMPLES WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13557 ANGIODYNAMICS CONVENIENCE KIT OEZ ANGIODYNAMICS H7496566087241

    Patients

    Seq Age Sex Outcome Treatment
    1