BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT¿

    MDR report key: 3033520 · Received April 3, 2013

    Report

    Report Number
    3005099803-2013-02281
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. (B)(4) FOR THE REPORTED EVENT OF NEEDLE FAILING TO RETRACT. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. (B)(4) FOR THE REPORTED EVENT OF NEEDLE FAILING TO RETRACT. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO ONE OF FOUR DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2013-02282, #3005099803-2013-02283, AND #3005099803-2013-02284 FOR A DESCRIPTION OF THE OTHER DEVICES. THIS REPORT IS FOR THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE NURSE WAS NOT ABLE TO RETRACT THE NEEDLE. PART OF THE NEEDLE WAS VISIBLE AFTER COMPLETE RETRIEVAL OF THE HANDLE; IT WOULD NOT GO BACK COMPLETELY INTO THE SHEATH. ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137308 INTERJECT¿ KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC - SPENCER M00518351 15847388

    Patients

    Seq Age Sex Outcome Treatment
    1