BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2100999 · Received May 24, 2011

    Report

    Report Number
    3005099803-2011-01732
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. 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

    A VISUAL ASSESSMENT OF THE RETURNED INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS PERFORMED. THE NEEDLE WAS EXTENDED; AND NO DAMAGE TO THE DEVICE WAS OBSERVED. A FUNCTIONAL EVALUATION WAS PERFORMED. THE NEEDLE EXTENDED AND RETRACTED WITHOUT ISSUE. A SECOND FUNCTIONAL EVALUATION WAS PERFORMED USING A SYRINGE FILLED WITH ONLY AIR; AN ATTEMPT TO INJECT AIR THROUGH THE DEVICE WAS MADE. RESISTANCE WAS FELT, AND AIR WAS NOT ABLE TO BE INJECTED THROUGH THE DEVICE. THE DEVICE WAS DISASSEMBLED, AND THE HUB AND EXTRUSION WERE ANALYZED; NO OBSTRUCTION WAS FOUND. THE NEEDLE WAS ANALYZED AND A PIN GAUGE WAS INSERTED INTO THE INNER DIAMETER. INITIALLY RESISTANCE WAS FELT, HOWEVER, NO FOREIGN MATTER WAS EXPELLED FROM THE NEEDLE. THE PIN GAUGE WAS REINSERTED, AND THERE WAS LESS RESISTANCE; EVENTUALLY THE PIN WAS ABLE TO BE INSERTED AND RETRACTED WITH EASE. BASED ON THE ANALYSIS, IT WAS DETERMINED THAT THE NEEDLE WAS INITIALLY OCCLUDED. THE SOURCE OF THE OBSTRUCTION IN THE NEEDLE COULD NOT BE DETERMINED. 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 POLYPECTOMY. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN FLUSHED THE NEEDLE WITH SALINE OUTSIDE OF THE PATIENT, HE FOUND THE NEEDLE LUMEN TO BE BLOCKED. ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED TO FINISH 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A POLYPECTOMY. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN FLUSHED THE NEEDLE WITH SALINE OUTSIDE OF THE PATIENT, HE FOUND THE NEEDLE LUMEN TO BE BLOCKED. ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED TO FINISH 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERJECT INJECTION THERAPY NEEDLE,MOD 1810,1811,1815,1816,1820,1821,1825,1826 KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC - SPENCER M00518311 14070562

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR