BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVAK - 400 MICRON FIBER PROCEDURE KIT

    MDR report key: 3905204 · Received June 11, 2014

    Report

    Report Number
    1319211-2014-00085
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K002101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MFR FOR EVAL. TO DATE THE DEVICE HAS YET TO BE RETURNED. ATTEMPTS ARE BEING MADE TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A F/U MEDWATCH. A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONFIRMED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS.

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014, A PT OF UNK AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. DURING PREPARATION FOR THE PROCEDURE, IT WAS NOTED THE TIP OF THE FIBER WAS DAMAGED. THE DISPOSABLE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PT DUE TO THE EVENT AS THE DISPOSABLE DEVICE DID NOT COME INTO CONTACT WITH THE PT. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345120 PVAK - 400 MICRON FIBER PROCEDURE KIT ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 006121

    Patients

    Seq Age Sex Outcome Treatment
    1