BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS

    MDR report key: 7641693 · Received June 27, 2018

    Report

    Report Number
    1317056-2018-00123
    Event Type
    Malfunction
    Date Received
    June 27, 2018
    Date of Event
    March 28, 2018
    Report Date
    June 26, 2018
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OEZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PACKAGING LOT (5230602) FOR ITEM NUMBER H749606916271 HAD COMPONENT (B)(4) (LOTS 5204001 AND 5224281) PACKAGED IN IT. 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 APRIL 2018 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE CONTRAST INJECTION LINE PRODUCT FAMILY AND THE FAILURE MODE "DEVICE LEAKED. " NO ADVERSE TREND WAS INDICATED. AS RECEIVED, THE 60" CONTRAST INJECTION LINE (CIL) WAS RETURNED WITH WHAT APPEARED TO BE DRIED CONTRAST INSIDE. A VISUAL INSPECTION UPON RECEIPT WAS PERFORMED. IT WAS NOTED DURING THE VISUAL INSPECTION THAT A PIECE OF THE O-RING WAS BROKEN AND WAS IN THE FLUID PATH OF THE CIL. AN AIR LEAK TEST WAS THEN PERFORMED WHICH CONFIRMED A LEAK AT THE O-RING SEAL. THE CUSTOMER'S COMPLIANT DESCRIPTION IS CONFIRMED. THE ROOT CAUSE OF LEAK WAS CAUSED BY A DAMAGED O-RING IN THE ROTATING ADAPTOR ASSEMBLY ON THE CIL. THE CIL IS MANUALLY ASSEMBLED. THE O-RING IS PLACED INTO THE CIL STEM CUP USING A STYLUS TOOL. THE ROTATING ADAPTER (RA) IS LUBRICATED, APPLIED ONTO THE STEM CUP AND THEN SWAGED ONTO THE CIL. THE DAMAGED O-RING IS A RESULT OF THE O-RING BEING PLACED AT AN ANGLE INSIDE THE CIL STEM CUP. CORRECT ORIENTATION OF THE O-RING IN THE STEM CUP IS HORIZONTAL, LYING FLAT IN THE BOTTOM OF THE STEM CUP. WITH THE O-RING TILTED, IT ALLOWS THE O-RING TO BE DAMAGED BY THE ROTATING ADAPTOR (RA) COMPONENT AS IT WAS ASSEMBLED ONTO THE STEM CUP AND SWAGED. WHEN THE ROTATING ADAPTOR (RA) IS PLACED ONTO THE STEM CUP WITH A TILTED O-RING A PORTION OF THE O-RING MAY BE FORCED INTO THE LUMEN BELOW THE STEM CUP OR THE O-RING MAY BE CUT. THE ROOT CAUSE OF THE O-RING BEING PLACED IN THE STEM CUP AT AN ANGLE WAS A RESULT OF OPERATOR ERROR DURING THE MANUAL ASSEMBLY PROCESS. THIS DEVICE NON-CONFORMANCE WAS NOT OBSERVED DURING THE 100% VISUAL INSPECTION OF THE RA/O-RING POST ASSEMBLE. TOOLING FOR APPLYING THE O-RING INTO THE STEM CUP, AND THE SWAGE MACHINE FOR THE SWAGING PROCESS OF THE RA WERE REVIEWED. NO ISSUES WERE DISCOVERED. CORRECTION/CORRECTIVE ACTIONS: ALL EMPLOYEES WHO WORKED ON THE CIL LOTS USED IN THE REPORTED PACKAGING LOT WERE RETRAINED ON THE APPLICABLE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY END USER HOSPITAL IN (B)(6), "LEAKAGE WAS OBSERVED FROM THE CONNECTION. ALTHOUGH SECURED AND TIGHTENED THE CONNECTION STILL LEAKED." O-RING IN MANIFOLD ROTATING ADAPTOR WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INJURY. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483056 ANGIODYNAMICS CONVENIENCE KIT OEZ ANGIODYNAMICS 5230602

    Patients

    Seq Age Sex Outcome Treatment
    1