BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS

    MDR report key: 6198457 · Received December 22, 2016

    Report

    Report Number
    1317056-2016-00191
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OEZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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) 2016 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE PERCEPTOR DTS AND MANIFOLDS PRODUCT FAMILY AND THE FAILURE MODE "AIR BUBBLES NOTED. " NO ADVERSE TREND WAS IDENTIFIED. EXAMINATION OF THE RETURNED SAMPLE SHOWED THE MALE SLIP OF THE ROTATING ADAPTOR OF THE MANIFOLD TO BE BROKEN OFF INSIDE THE FEMALE LUER OF THE CONTRAST INJECTION LINE (CIL) WHICH WAS BONDED TO IT. THE SLIP IS FIRMLY ATTACHED TO THE INSIDE OF THE FEMALE LUER. THE BOND BETWEEN THE FEMALE OF THE CIL AND THE ROTATING ADAPTOR OF THE MANIFOLD SHOWED NO EVIDENCE OF EXCESS BONDING AGENT. LEAK TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED SAMPLE. BASED ON THE SAMPLE EVALUATION RESULTS AND PROCESS CONTROLS IN PLACE TO ADDRESS THIS FAILURE MODE, POSSIBLE ROOT CAUSES INCLUDE THE END USER TRYING TO TIGHTEN THE BONDED CONNECTION, HANDLING DAMAGE DURING TRANSIT OR THAT THE RESPONSIBLE EMPLOYEES DID NOT APPLY ENOUGH CHEMICAL ADHESIVE WHEN ATTACHING THE ROTATING ADAPTOR. NO OTHER DAMAGE WAS NOTED TO THE RETURNED SAMPLE. THE EMPLOYEES INVOLVED IN THE ASSEMBLY OF THE REPORTED DEVICE LOT HAVE BEEN MADE AWARE OF THIS EVENT AND THE APPLICABLE BONDING PROCEDURE HAS BEEN REVIEWED WITH THEM. (B)(4).

    Additional Manufacturer Narrative · 1

    IT HAS BEEN STATED THAT THE DEVICE FROM THE REPORTED EVENT WILL BE RETURNED TO ANGIODNAMICS FOR EVALUATION, HOWEVER IT HAS NOT YET ARRIVED. UPON RECEIPT OF THE SAMPLE / COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), AIR WAS ASPIRATED INTO THE FLUID PATH OF A COMPONENT WITHIN A CONVENIENCE KIT DURING A CARDIAC CATHETERIZATION PROCEDURE. THE AIR WAS NOT INJECTED INTO THE PATIENT. THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848157 ANGIODYNAMICS CONVENIENCE KIT OEZ ANGIODYNAMICS 5069293

    Patients

    Seq Age Sex Outcome Treatment
    1