BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 5021528 · Received August 14, 2015

    Report

    Report Number
    1319211-2015-00323
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE REPORTED COMPLAINT SAMPLE WAS DISPOSED OF BY THE USER AND NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. ALTHOUGH THE REPORTED DEVICE WAS NOT RETURNED, BASED ON A PHOTOGRAPH PROVIDED BY THE USER, THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION WAS CONFIRMED FOR DAMAGE TO THE POUCH. THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS HANDLING DAMAGE THAT OCCURRED DURING TRANSIT AFTER LEAVING THE ANGIODYNAMICS FACILITY. THERE ARE THREE MANUFACTURING PROCEDURES, PERFORMED DURING PACKAGING, IN WHICH OPERATORS ARE INSTRUCTED TO VISUALLY INSPECT FOR DAMAGE ON THE POUCH. IT IS UNLIKELY THAT THE DAMAGE WAS PRESENT DURING MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2015 WHEN RECEIVING THE DEVICES AT THE MEDICAL FACILITY, UPON OPENING THE SHIPPER BOX, IT WAS NOTED THE VENDOR SEAL OF THE STERILE PACKAGING WAS TORN. AS THE ISSUE WAS NOTED UPON RECEIPT OF THE PRODUCT, THERE WAS NO PATIENT CONTACT WITH THE DEVICE. IT WAS REPORTED THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISPOSED OF BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539693 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS, INC. 4899039

    Patients

    Seq Age Sex Outcome Treatment
    1