BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLO INJECTION NEEDLE

    MDR report key: 1230753 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05518
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K953338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MFR DATE IS UNK. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVAL CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED THAT DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE, THE NEEDLE OF AN OPTIFLO INJECTION NEEDLE DEVICE FAILED TO RETRACT. THE DEVICE WAS REMOVED AND REPLACED WITH SECOND OPTIFLO INJECTION NEEDLE DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PT'S CONDITION WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLO INJECTION NEEDLE KOG BOSTON SCIENTIFIC CORPORATION M00511751 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK