BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11G 5" MATCH-GROUND FOUR FACT TIP INTRODUCTION NEEDLE

    MDR report key: 3950095 · Received July 22, 2014

    Report

    Report Number
    0001811755-2014-02609
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 9, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KNW
    PMA / PMN Number
    K032943
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE, THE 2 LOTS OF 11G 5" MATCH-GROUND FOUR FACT TIP INTRODUCTION NEEDLE (FX87) ARE BEING REPORTED SEPARATELY FROM THE 1 LOT OF 11G 5" MATCH-GROUND FOUR FACT TIP INTRODUCTION NEEDLE (FRT3). THE MFR REPORT # WILL BE SPECIFIED WITH THE SUPPLEMENTAL REPORT. AWAITING CONFIRMATION FROM THE CUSTOMER AS TO WHETHER OR NOT THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A SERVICE TECHNICIAN VISUALLY EVALUATED THE DEVICE AND FOUND THAT THE RETURNED DEVICE HAS A FRACTURED TIP. THE DEVICE WAS SCRAPPED BY THE MANUFACTURER. BASED ON REVIEW OF THE INSTRUCTIONS FOR USE, A POSSIBLE CAUSE COULD BE CONTRIBUTED TO USER HANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PROCEDURE, THE TIP OF THREE 11 G 5'' MATCH-GROUND FOUR FACT TIP INDUCTION NEEDLES BROKE OFF. IT WAS REPORTED THAT THE THREE METAL FRAGMENTS WERE UNABLE TO BE EXTRACTED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PROCEDURE, THE TIP OF THREE 11 G 5'' MATCH-GROUND FOUR FACT TIP INDUCTION NEEDLES BROKE OFF. IT WAS REPORTED THAT THE THREE METAL FRAGMENTS WERE UNABLE TO BE EXTRACTED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428698 11G 5" MATCH-GROUND FOUR FACT TIP INTRODUCTION NEEDLE INSTRUMENT, BIOPSY KNW STRYKER INSTRUMENTS-KALAMAZOO FX87

    Patients

    Seq Age Sex Outcome Treatment
    1 Other