BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER NEO-VERSO INFANT/NEO Y W/DIR CON

    MDR report key: 6209166 · Received December 28, 2016

    Report

    Report Number
    2050001-2016-00036
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    December 2, 2016
    Report Date
    June 6, 2017
    Manufacturer
    AOK TOOLING LIMITED
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT SAMPLE WAS RECEIVED AND AN EVALUATION WAS COMPLETED. THE INVESTIGATION INTO THE REPORTED FAILURE WAS UNABLE TO DUPLICATE THE REPORTED ISSUE AND THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE DEVICE BECOMES AVAILABLE, AN INVESTIGATION WILL BE COMPLETED AND A FOLLOW UP EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    UNDER INVESTIGATION IT WAS STATED VIA EMAIL "HEY (B)(6), I LEFT ONE OF THE NEW ETT T-CONNECTOR PIECES IN YOUR MAILBOX OVER THE WEEKEND, AND I PLANNED ON WRITING AN EMAIL BUT DIDN'T GET TO IT FRIDAY NIGHT. SO THIS PIECE WAS ON 843S TUBE AND LIKE THREE HOURS INTO MY NIGHT SHIFT I FIGURED OUT IT WAS BROKEN. SHE WAS REINTUBATED AT SOME POINT FRIDAY DAY SO IT WAS ONLY ON THERE MAYBE LIKE 8 HOURS. FOR THE FIRST TWO HOURS OF MY SHIFT SHE WAS RINGING OFF FOR VOLUME ISSUES AND ALSO I NOTICED HER LEAK WAS BIGGER, AND THEN AFTER A BAD EPISODE WHEN I WENT TO PUT A SALINE BULLET DOWN HER TUBE I NOTICED WATER WAS SPRAYING OUT FROM SOMEWHERE AND THEN WHILE BAGGING HER I COULD FEEL/HEAR SOME AIR COMING FROM THE TUBE AS WELL. I NOTICED THAT THE PLASTIC PART ON CONNECT THAT READS '3.5' WAS VERY EASILY SPINNING AROUND THE PIECE. WITH THESE BEING NEW I COULDN'T REMEMBER IF THAT WAS SUPPOSED TO HAPPEN BUT I FIGURED NOT AND I CHECK ANOTHER PATIENTS TUBE AND THEIRS DID NOT SPIN. SO WE REMOVED THE PIECE AND PUT A NEW ONE ON AND WHEN I OPENED THE NEW PACK I NOTICED THAT THERE WAS AN O-RING AROUND THE BIGGER PIECE THAT CONNECTS ONTO THE BOTTOM CONNECTOR PIECE AND THAT IT LOCKED IN VERY WELL WITH NOT MUCH MOVEMENT. SO I ASSUMED THAT THE O-RING WAS MISSING IN THE DEFECTIVE PIECE AND THEN MIRACULOUSLY WHEN I WEIGHED HER AT MIDNIGHT AND CHANGED HER SHEETS AND OUTFIT I ACTUALLY FOUND THE O-RING IN HER BED. MUST HAVE FALLEN OFF WHEN THEY OPENED THE PACK PUTTING THE NEW ONE WHEN SHE WAS REINTUBATED. NO ONE KNEW WHAT I WAS TALKING ABOUT WHEN I WAS ASKING ABOUT THE PIECE OR KNEW IF IT WAS SUPPOSED TO SPIN OR NOT. WHEN I TOLD PEOPLE ABOUT THE O-RING PEOPLE DIDN'T KNOW EITHER. I THINK THAT EVEN THOUGH IT WAS A MINIMAL EFFECT IT STILL CAUSED ISSUES WITH HER BEING ACCURATELY VENTILATED BECAUSE ONCE CHANGED THE VENT DIDN'T ALARM ANYMORE. WAS ANYONE INJURED? NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858484 ADAPTER NEO-VERSO INFANT/NEO Y W/DIR CON CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI AOK TOOLING LIMITED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention