BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS

    MDR report key: 7286978 · Received February 21, 2018

    Report

    Report Number
    1317056-2018-00016
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    January 26, 2018
    Report Date
    April 30, 2018
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OEZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING LOT 5253358 FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOT MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE RECENT ANGIODYNAMICS COMPLAINT REPORT WAS PERFORMED FOR THE CONVENIENCE KIT PRODUCT FAMILY AND THE FAILURE MODE " INCORRECTLY CONSTRUCTED/ASSEMBLED. " NO ADVERSE TREND WAS INDICATED. TWO UNOPENED CONVENIENCE KITS WERE RETURNED FOR EVALUATION, AND THE ISSUE OF A BLUE NON-VENTED DUST CAP CONNECTED TO THE PRESSURE MONITORING LINE FITTING WAS CONFIRMED. THE REPORTED LOT CONSISTED OF 300 KITS ALL SHIPPED TO THE DISTRIBUTOR IN JAPAN. THE DISTRIBUTOR PERFORMED A 100% VISUAL INSPECTION AND LABELING PROCESS AND FOUND 2 OF 300 KITS (0.67% FAILURE RATE) TO HAVE THE INCORRECT (NON-VENTED) PORT PROTECTOR ATTACHED TO THE PRESSURE MONITORING LINE FITTING. THE ROOT CAUSE OF THE INCORRECT CAP ATTACHMENT HAS BEEN DETERMINED TO BE A MANUFACTURING ASSEMBLY ERROR. IN AN EFFORT TO HEIGHTEN AWARENESS OF THE PERFORMANCE OF OUR PRODUCTS IN THE FIELD, RECENT COMPLAINTS ARE REVIEWED IN A WEEKLY MEETING WITH THE ENTIRE DEPARTMENT. ALL RESPONSIBLE PACKAGING EMPLOYEES HAVE BEEN RETRAINED ON THE APPLICABLE PROCEDURES. REVISIONS HAVE BEEN INITIATED TO TWO ASSEMBLY/PACKAGING PROCEDURES TO CHANGE FROM "ONE-PIECE FLOW" TO "TEN-PIECE FLOW". THE TEN-PIECE FLOW PROCESS WILL REQUIRE INTERIM CHECKS DURING THE ASSEMBLY/PACKAGING PROCESS TO CONFIRM ALL COMPONENT QUANTITIES ARE CORRECT. A REVIEW OF THE REPORTING CUSTOMER'S CONVENIENCE KITS SHOWED THAT THIS UPN (B)(4) IS THE ONLY KIT THAT HAS THIS BLUE NON-VENTED PORT PROTECTOR CAP CONNECTED TO A DEVICE. ITEM # H749606918321 (WITH NON-VENTED BLUE CAP CONNECTED TO MANIFOLD END PORT) HAS BEEN INACTIVATED; NEW ITEM # (B)(4) WITH VENTED CAP CONNECTED TO MANIFOLD END PORT) HAS BEEN CREATED. (PR (B)(4)).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING LOT FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOT MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ANGIODYNAMICS' JANUARY COMPLAINT REPORT WAS REVIEWED FOR THE CONVENIENCE KIT PRODUCT FAMILY AND THE FAILURE MODE, " ASSEMBLED INCORRECTLY. " NO ADDITIONAL COMPLAINTS RELATED TO STERILIZATION CONCERNS DUE TO THE ASSEMBLY PROCESS WERE PRESENT. THE REPORTED LOT CONSISTED OF 300 KITS ALL SHIPPED TO THE DISTRIBUTOR IN (B)(6). THE DISTRIBUTOR PERFORMED A 100% VISUAL INSPECTION AND LABELING PROCESS AND FOUND 2 OF 300 KITS (0.67% FAILURE RATE) TO HAVE THE INCORRECT (NON-VENTED) PORT PROTECTOR ATTACHED TO THE PRESSURE MONITORING LINE FITTING. THE INVESTIGATION INTO THIS REPORTED EVENT IS ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN JAPAN, DURING UNPACKING / INSPECTION AT THE DISTRIBUTOR'S WAREHOUSE, 2 UNITS OF A STERILE CONVENIENCE KIT WERE NOTED TO HAVE BLUE, NON-VENTED PORT PROTECTORS ATTACHED TO THE PRESSURE MONITORING LINE (PML) WITHIN THE KIT, INSTEAD OF WHITE, VENTED PORT PROTECTORS. THE VENTED PORT PROTECTOR ALLOWS FOR A STERILIZATION PATH INTO THE PML AND A PORTION OF THE MANIFOLD TO WHICH THE LINE IS ATTACHED. WITH THE NON-VENTED PORT PROTECTOR ATTACHED TO THE PML, THERE IS NO DIRECT PATHWAY FOR STERILIZATION INTO THE PML AND MANIFOLD. THE LUMEN OF THE PML AND MANIFOLD ARE POTENTIALLY NON-STERILE AS ANDIODYNAMICS DOES NOT HAVE STERILIZATION TESTING ON FILE CHALLENGING THIS NON-VENTED PACKAGING CONFIGURATION. THE KIT HAD NOT BEEN DISTRIBUTED TO A HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130647 ANGIODYNAMICS CONVENIENCE KIT OEZ ANGIODYNAMICS 5253358

    Patients

    Seq Age Sex Outcome Treatment
    1