BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION NEEDLE

    MDR report key: 1990023 · Received February 15, 2011

    Report

    Report Number
    3005099803-2011-00364
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K953338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    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 #3005099803-2011-00363, AND #3005099803-2011-00365 FOR A DESCRIPTION OF THE OTHER DEVICES. THIS REPORT IS FOR THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A OPTIFLO INJECTION NEEDLE DEVICE WAS INTENDED FOR USE FOR HEMOSTASIS, DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE NEEDLE DID NOT RETRACT PROPERLY DURING TESTING. THIS NEEDLE ALSO DID NOT EXTEND PROPERLY, DURING THE PROCEDURE. THEY TOOK A SECOND OPTIFLO INJECTION NEEDLE DEVICE, AND THIS ALSO DID NOT RETRACT. A THIRD OPTIFLO INJECTION NEEDLE WAS TESTED OUTSIDE OF THE PATIENT, AND THIS WOULD NOT RETRACT. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER COMPANY'S NEEDLE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. HOWEVER, THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION NEEDLE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00511751 0000750823

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR