BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT?

    MDR report key: 3033504 · Received April 3, 2013

    Report

    Report Number
    3005099803-2013-02283
    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. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE NEEDLE WAS PARTIALLY RETRACTED WHEN RECEIVED. NO KINKS WERE FOUND ON THE WORKING LENGTH. A TORTUOUS TEST WAS PERFORMED ON THE DEVICE IN TWO INCH DOUBLE LOOPS. THE NEEDLE EXTENDED AND RETRACTED WITHOUT ISSUE, WHEN THE INNER HUB WAS ACTUATED. THE REPORTED FAILURE MODE COULD NOT BE REPLICATED DURING THE INVESTIGATION. THE ROOT CAUSE FOR THIS COMPLAINT WAS NOT ABLE TO BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    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 #3005099803-2013-02281, #3005099803-2013-02282, AND #3005099803-2013-02284 FOR A DESCRIPTION OF THE OTHER DEVICES. THIS REPORT IS FOR THE THIRD DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS INTENDED FOR USE DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING INSPECTION THE STOCK SUPPLY AT THE HOSPITAL, THE NURSE SAW THAT THE NEEDLE WAS STICKING OUT OF THE SHEATH, WHILE THE NEEDLE WAS STILL IN THE PACKAGING. AFTER TAKING THE DEVICE OUT OF THE PACKAGING, THE NURSE ATTEMPTED TO RETRACT THE NEEDLE, BUT IT WOULD NOT GO BACK COMPLETELY INTO THE SHEATH. THIS DEVICE WAS NOT USED IN THE PROCEDURE. ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS 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.

    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 #3005099803-2013-02281, #3005099803-2013-02282, AND #3005099803-2013-02284 FOR A DESCRIPTION OF THE OTHER DEVICES. THIS REPORT IS FOR THE THIRD DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS INTENDED FOR USE DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING INSPECTION THE STOCK SUPPLY AT THE HOSPITAL, THE NURSE SAW THAT THE NEEDLE WAS STICKING OUT OF THE SHEATH, WHILE THE NEEDLE WAS STILL IN THE PACKAGING. AFTER TAKING THE DEVICE OUT OF THE PACKAGING, THE NURSE ATTEMPTED TO RETRACT THE NEEDLE, BUT IT WOULD NOT GO BACK COMPLETELY INTO THE SHEATH. THIS DEVICE WAS NOT USED IN THE PROCEDURE. ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS 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
    137289 INTERJECT? KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC - SPENCER M00518351 15847388

    Patients

    Seq Age Sex Outcome Treatment
    1