BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT INJECTION THERAPY NEEDLE,MOD 1810,1811,1815,1816,1820,1821,1825,1826

    MDR report key: 2895479 · Received January 3, 2013

    Report

    Report Number
    3005099803-2012-06423
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF NEEDLE BEING BROKEN. 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE NEEDLE WAS PRESENT AND ATTACHED. WHEN THE INNER HUB WAS ACTUATED, THE NEEDLE WOULD EXTEND AND RETRACT WITHOUT ISSUE, EVEN WHEN HELD STRAIGHT AND WHEN HELD IN TWO 2 INCH LOOPS. THERE WERE NO COMPONENTS SEPARATED OR TORN APART. THE OUTER SHEATH WAS FOUND TO BE KINKED IN SEVERAL LOCATIONS; LIKELY DUE TO OPERATIONAL ASPECTS OF THE PROCEDURE. THE COMPLAINANT CONFIRMED THAT THE RETURNED DEVICE WAS THE DEVICE REPORTED TO BE DEFECTIVE. HOWEVER, BASED UPON THE EVALUATION CONDUCTED, THE REPORT OF THE NEEDLE NOT EXTENDING, THE NEEDLE BECOMING STUCK IN THE SHEATH AND BREAKING OFF, COULD NOT BE CONFIRMED; THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONALLY, AS THE NEEDLE WAS ATTACHED AND NOT BROKEN OFF, THIS EVENT IS NO LONGER CONSIDERED A MDR- REPORTABLE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE NEEDLE WOULD NOT EXTEND AGAIN ONCE RETRACTED THE FIRST TIME; IT BECAME STUCK IN THE SHEATH AND BROKE OFF. THE NEEDLE REMAINED STUCK INSIDE OF THE SHEATH. NO DAMAGED HAD BEEN NOTED TO THE DEVICE PACKAGING. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE NEEDLE WOULD NOT EXTEND AGAIN ONCE RETRACTED THE FIRST TIME; IT BECAME STUCK IN THE SHEATH AND BROKE OFF. THE NEEDLE REMAINED STUCK INSIDE OF THE SHEATH. NO DAMAGED HAD BEEN NOTED TO THE DEVICE PACKAGING. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2056 INTERJECT INJECTION THERAPY NEEDLE,MOD 1810,1811,1815,1816,1820,1821,1825,1826 KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC - SPENCER M00518150 14259504

    Patients

    Seq Age Sex Outcome Treatment
    1