BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ SYRINGE KIT

    MDR report key: 3193338 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03183
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    August 25, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    NDN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE INVESTIGATION OF THE RETURNED ITEMS SHOWED THAT THE NEEDLE IS ACTUALLY BROKEN AT THE CANNULA CONNECTION. NO PRODUCT DEFECTS COULD BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE WAS BROKEN DURING REMOVAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293437 VERTECEM V+ SYRINGE KIT NDN SYNTHES USA 0104125

    Patients

    Seq Age Sex Outcome Treatment
    1