BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION NEEDLE

    MDR report key: 2014023 · Received March 10, 2011

    Report

    Report Number
    3005099803-2011-00782
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K953338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLO INJECTION NEEDLE WAS INTENDED FOR USE DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE NURSE FOUND THAT THERE WAS A RAZOR IN THE STERILE PACKAGING OF THE DEVICE. NO ONE WAS HARMED BY THE RAZOR. THE PACKAGE WAS SET ASIDE, AND A NEW OPTIFLO 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLO INJECTION NEEDLE WAS INTENDED FOR USE DURING A COLONOSCOPY PROCEDURE.ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE NURSE FOUND THAT THERE WAS A RAZOR IN THE STERILE PACKAGING OF THE DEVICE. NO ONE WAS HARMED BY THE RAZOR. THE PACKAGE WAS SET ASIDE, AND A NEW OPTIFLO 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION NEEDLE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00511751 0000757843

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR