BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS

    MDR report key: 6128459 · Received November 28, 2016

    Report

    Report Number
    1317056-2016-00169
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 1, 2016
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DTL
    UDI-DI
    H965700550091
    PMA / PMN Number
    K842829
    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 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 (B)(6) 2016 COMPLAINT REPORT WAS REVIEWED FOR THE STOPCOCKS PRODUCT FAMILY AND THE FAILURE MODE,"HOLE IN POUCH." NO ADVERSE TRENDS WERE IDENTIFIED. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND THE HOLE IN THE POUCH WAS CONFIRMED. THE ROOT CAUSE OF THE HOLE IS THE HANDLE FROM THE STOPCOCK PRESSES OUTWARD AGAINST THE TYVEK. AS PART OF THE RECEIVING PROCESS AT NIPRO (THE DISTRIBUTOR IN (B)(4)), ALL POUCHED PRODUCTS ARE REMOVED FROM THEIR INNER BOXES AND A NIPRO LABEL (IN (B)(4)) IS APPLIED TO EACH POUCH. ADDITIONAL HANDLING MAY OCCUR IF PRODUCT IS 100% VISUALLY INSPECTED. THE POUCHED PRODUCT IS THEN RE-BOXED INTO THE INNER BOX BY THE NIPRO WAREHOUSE EMPLOYEES. THE HOLE IN THE TYVEK WAS LIKELY CAUSED BY THE HANDLE OF A STOPCOCK IN THE POUCH, HOWEVER, WHAT CAUSED THE HANDLE TO BE PUSHED AGAINST THE TYVEK IN A MANNER THAT RESULTED IN A HOLE CANNOT BE DETERMINED. POTENTIAL CONTRIBUTING FACTORS INCLUDE: - HANDLING OF THE POUCHES AS THEY ARE PLACED IN THE INNER BOXES. - HANDLING DURING TRANSIT TO NIPRO WAREHOUSE. - HANDLING DURING NIPRO LABELING/INSPECTION AND RE-BOXING PROCESS. ALL POUCHES ARE 100% INSPECTED PER ANGIODYNAMICS PROCEDURES DURING THE SEALING AND FINAL BOX PROCESSES. THE DIRECTIONS FOR USE (DFU) PACKAGED WITH THE KITS CONTAIN THE FOLLOWING WARNING: "CONTENTS SUPPLIED STERILE USING AN ETHYLENE OXIDE (EO) PROCESS. DO NOT USE IF STERILE BARRIER IS DAMAGED." (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4) , IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779139 ANGIODYNAMICS STOPCOCK HIGH PRESSURE DTL ANGIODYNAMICS 5064228 H965700550091

    Patients

    Seq Age Sex Outcome Treatment
    1