BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPIRA CITOJECT

    MDR report key: 2897597 · Received December 6, 2012

    Report

    Report Number
    9681707-2012-00011
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 6, 2012
    Product Code
    EJI
    PMA / PMN Number
    K842006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION# (B)(4), (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MFR). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT OUT OF CAUTION TO BE COMPLAINT WITH 21 CFR PART 803. THIS PRODUCT IS SOLD IN THE US UNDER THE CATALOG MODEL # 66002394. IT IS ONLY DIFFERENT IN THAT THE US DISTRIBUTED CITOJET HAS A STANDARD THREAD. THE UNIT IN THIS HAS METRIC THREADING. THE US DISTRIBUTED CITOJET HAS BEEN ON THE MARKET WITHOUT INCIDENT SINCE 1985. CONCLUSIONS: THE DEVICE HAS A ONE YEAR GUARANTEE AGAINST DEFECTS. THE UNIT IN THIS REPORT IS WELL OUTSIDE THIS GUARANTEE PERIOD. LONG TERM USAGE AND HANDLING COULD HAVE CONTRIBUTED TO THE MALFUNCTION. THE DIRECTIONS FOR USE STATE, "PLEASE FOLLOW THESE INSTRUCTIONS TO MAINTAIN YOUR SOPIRA CITOJET SYRINGE ALWAYS IN PERFECT WORKING CONDITION" AND "PLEASE USE NEEDLES WITH PLASTIC HUB ONLY. A METAL HUB CAN DAMAGE THREADED NOZZLE OF THE BARREL IN THE LONG TERM." THE DEVICE HAS NOT BEEN RETURNED TO THE MFR THEREFORE, THERE IS NO WAY TO DETERMINE THE CAUSE OF THE MALFUNCTION.

    Description of Event or Problem · 1

    DEALER NOTIFIED HERAEUS OF A CITOJET THAT THE DENTIST ALLEGES, "PLUNGER BREAKS THE ANESTHETIC CARTRIDGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPIRA CITOJECT EJI SYRINGE, CARTRIDGE EJI BARREL ANG. 1.8ML Y-08

    Patients

    Seq Age Sex Outcome Treatment
    1