BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION NEEDLE

    MDR report key: 2073631 · Received May 2, 2011

    Report

    Report Number
    3005099803-2011-01523
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K953338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. 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 THREE DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2011-01524, AND #3005099803-2011-01525 FOR A DESCRIPTION OF THE OTHER DEVICES. THIS REPORT IS FOR THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE OPTIFLO INJECTION NEEDLE DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE COLONOSCOPY PROCEDURE, THE NEEDLE WAS PUSHED OUT OF THE FIRST OPTIFLO INJECTION NEEDLE DEVICE. HOWEVER, THEY WERE UNABLE TO RETRACT THE NEEDLE. THE SAME ISSUE OCCURRED WITH TWO ADDITIONAL OPTIFLO INJECTION NEEDLE DEVICES. THE PROBLEM OCCURRED OUTSIDE THE PATIENT IN EACH CASE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER OPTIFLO INJECTION NEEDLE DEVICE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION NEEDLE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00511731 0000780276

    Patients

    Seq Age Sex Outcome Treatment
    1