BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC WING GRN 18GA X 1.16IN

    MDR report key: 8584294 · Received May 6, 2019

    Report

    Report Number
    1710034-2019-00502
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 15, 2019
    Report Date
    June 13, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903826446
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RETRACTION FAILURE OCCURRED WITH A INSYTE AUTOG BC WING GRN 18GA X 1.16IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO: 382644 BATCH NO: 7222872. IT WAS REPORTED THAT NEEDLES ARE NOT DISENGAGING FROM THE CATHETER ONCE PLACED INSIDE THE VEIN. THE ENTIRE DEVICE HAD TO BE REMOVED FROM THE PATIENT, AND THE NEEDLE WOULD NOT RETRACT AFTER SEVERAL ATTEMPTS. PER CUSTOMER EMAIL: JUST WANTED TO MAKE YOU AWARE THAT I HAVE BEEN HAVING PROBLEMS WITH INTS NEEDLES NOT DISENGAGING FROM THE CATHETER ONCE PLACED INSIDE THE VEIN. TONIGHT THIS HAPPENED AGAIN JUST AFTER INTUBATING A PATIENT IN THE ICU. I PLACED AN 18G FOR POSSIBLE NEED OF CRITICAL DRIPS. GOOD FLASH RETURNED BUT WHEN I TRIED TO REMOVE THE NEEDLE IT WOULD NOT COME INTO THE SAFETY DEVICE. I TRIED TO SLIDE IT OFF THE NEEDLE AND IT WOULD NOT. I HAD TO REMOVE THEN ENTIRE DEVICE FROM THE PATIENT. WE THEN ATTEMPTED TO RETRACT THE NEEDLE SEVERAL TIMES AND IT WOULD NOT. I KEPT THE WRAPPER FROM THIS ONE SINCE I HAVE HAD SEVERAL NOW TO DO THIS."

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RETRACTION FAILURE OCCURRED WITH A INSYTE AUTOG BC WING GRN 18GA X 1.16IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO: 382644, BATCH NO: 7222872. IT WAS REPORTED THAT NEEDLES ARE NOT DISENGAGING FROM THE CATHETER ONCE PLACED INSIDE THE VEIN. THE ENTIRE DEVICE HAD TO BE REMOVED FROM THE PATIENT, AND THE NEEDLE WOULD NOT RETRACT AFTER SEVERAL ATTEMPTS. PER CUSTOMER EMAIL: JUST WANTED TO MAKE YOU AWARE THAT I HAVE BEEN HAVING PROBLEMS WITH INTS NEEDLES NOT DISENGAGING FROM THE CATHETER ONCE PLACED INSIDE THE VEIN. TONIGHT THIS HAPPENED AGAIN JUST AFTER INTUBATING A PATIENT IN THE ICU. I PLACED AN 18G FOR POSSIBLE NEED OF CRITICAL DRIPS. GOOD FLASH RETURNED BUT WHEN I TRIED TO REMOVE THE NEEDLE IT WOULD NOT COME INTO THE SAFETY DEVICE. I TRIED TO SLIDE IT OFF THE NEEDLE AND IT WOULD NOT. I HAD TO REMOVE THEN ENTIRE DEVICE FROM THE PATIENT. WE THEN ATTEMPTED TO RETRACT THE NEEDLE SEVERAL TIMES AND IT WOULD NOT. I KEPT THE WRAPPER FROM THIS ONE SINCE I HAVE HAD SEVERAL NOW TO DO THIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374315 INSYTE AUTOG BC WING GRN 18GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7222872 30382903826446

    Patients

    Seq Age Sex Outcome Treatment
    1 Other