BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION NEEDLE

    MDR report key: 1651845 · Received April 6, 2010

    Report

    Report Number
    3005099803-2010-01570
    Event Type
    Malfunction
    Date Received
    April 6, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K953338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. THE REPORTED COMPLAINT WAS NOT ABLE TO BE CONFIRMED; NO PROBLEM WAS FOUND. ONCE THE OPTIFLO NEEDLE WAS EXTENDED, THE DEVICE WORKED PROPERLY. THE OPTIFLO WAS THEN TESTED USING A SYRINGE WITH WATER, AND NO OCCLUSION WAS FOUND; THE WATER CAME OUT WITHOUT RESTRICTIONS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLO INJECTION NEEDLE DEVICE WAS INTENDED FOR USE DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING TESTING OF THE DEVICE, THEY WERE NOT ABLE TO GET THE MEDICINE TO COME OUT OF THE NEEDLE. THEY WERE ALSO UNABLE TO RETRACT THE NEEDLE. ANOTHER OF THE SAME TYPE OF DEVICE WAS USED TO COMPLETE 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 OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLO INJECTION NEEDLE DEVICE WAS INTENDED FOR USE DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING TESTING OF THE DEVICE, THEY WERE NOT ABLE TO GET THE MEDICINE TO COME OUT OF THE NEEDLE. THEY WERE ALSO UNABLE TO RETRACT THE NEEDLE. ANOTHER OF THE SAME TYPE OF DEVICE WAS USED TO COMPLETE 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 OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION NEEDLE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00511731 0000680657

    Patients

    Seq Age Sex Outcome Treatment
    1