BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLO INJECTION NEEDLE

    MDR report key: 1222875 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06094
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBK
    PMA / PMN Number
    K953338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN OPTIFLO INJECTION NEEDLE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE DID NOT FUNCTION CORRECTLY. THE NEEDLE DID NOT COME OUT OF THE SHEATH COMPLETELY, AND WHEN DONE, THE NEEDLE WOULD NOT RETRACT. THE PROCEDURE WAS COMPLETED WITH THIS 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." THIS IS ONE OF THREE DEVICES THAT MALFUNCTIONED DURING THIS PROCEDURE. FOR DETAILS OF THE OTHER DEVICES REFER TO MANUFACTURER REPORT #3005099803-2008-06093 AND MFR #3005099803-2008-06095.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLO INJECTION NEEDLE FBK BOSTON SCIENTIFIC CORPORATION M00511731 0000606996

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK