BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT INJECTION THERAPY NEEDLE

    MDR report key: 1181621 · Received September 25, 2008

    Report

    Report Number
    3005099803-2008-04842
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTES: THIS REPORT IS THE SECOND OF TWO REPORTED MALFUNCTIONS WHICH OCCURRED DURING THE PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2008-XXXXX FOR DETAILS REGARDING THE FIRST DEVICE. DATE OF EVENT IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "THE NEEDLE WOULD NOT EXTEND PROPERLY." THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE; THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERJECT INJECTION THERAPY NEEDLE FCG BOSTON SCIENTIFIC CORPORATION M00518361 11812976

    Patients

    Seq Age Sex Outcome Treatment
    1