BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPAK

    MDR report key: 7294191 · Received February 24, 2018

    Report

    Report Number
    3004551550-2018-89991
    Event Type
    Malfunction
    Date Received
    February 24, 2018
    Date of Event
    October 21, 2017
    Report Date
    February 23, 2018
    Manufacturer
    TYTEK MEDICAL, INC.
    Product Code
    GAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TENSION PNEUMOTHORAX DECOMPRESSION NEEDLE/CATHETER WAS USED ON A GUNSHOT PATIENT BY EMS. ON ARRIVAL TO THE EMERGENCY ROOM, CHEST TUBES WERE INSERTED UNDER POOR LOCAL ANESTHESIA AND REQUIRED PHYSICALLY RESTRAINING THE PATIENT FROM BOTH SIDES OF THIS BODY. AFTER INSERTION OF THE TUBES, THE TRAUMA SURGEON OBSERVED THAT THE HUB FOR THE CATHETER WAS NOT PRESENT. IT WAS LATER DETERMINED THAT THE CATHETER WAS IN THE CHEST AND REQUIRED SURGICAL PROCEDURE TO REMOVE IT. IT WAS REPORTED THAT AFTER REMOVAL OF THE CATHETER THAT THE PATIENT WAS HEMODYNAMICALLY STABLE AND OXYGENATED WELL. DEVICE COMPONENTS WERE NOT RETAINED AT THE MEDICAL FACILITY AND COULD NOT BE MADE AVAILABLE FOR EVALUATION. IT IS THEREFORE NOT POSSIBLE TO DETERMINE IF THE FAILURE WAS DUE TO A FAULTY PRODUCT OR DAMAGE DURING THE PHYSICAL RESTRAINT EFFORTS REQUIRED TO INSERT THE CHEST TUBES. IT WAS REPORTED THAT THE DEVICE WAS PRESENT AND INTACT FROM THE POINT OF INITIAL INSERTION IN THE FIELD UP TO THE TIME PRIOR TO INSERTION OF THE CHEST TUBES. A LATER MORE DETAILED REPORT OF THE EVENTS WAS PROVIDED BY (B)(6), MD., MEDICAL DIRECTOR, (B)(6). HE INVESTIGATED AND CONFIRMED THAT THEY DID NOT HAVE A SAMPLE TO RETURN. IN DR. (B)(6)'S REPORT, HE RECEIVED INFORMATION FROM TERESA HILL WHO IS A SENIOR PERFORMANCE IMPROVEMENT SPECIALIST WITH TRAMA/ACUTE CARE SURGERY AT (B)(6) HOSPITAL WHERE THE PATIENT WAS TAKEN. MS. (B)(6) REPORTED, "I DON'T BELIEVE THERE WAS AN ISSUE WITH INSERTION, I WANTED TO ALERT YOUR TEAM IN THE EVENT THERE IS ANY OTHER FUTURE DEVICE FAILURES. IT MAY HAVE BEEN COMPROMISED IN THE PROCESS OF RESUSCITATING THE PATIENT SINCE THERE WAS AN APPROACH FROM BOTH SIDES TO PLACE CHEST TUBES. THE (QI) TAPE DOES NOT CLEARLY SHOW THE NEEDLE DECOMPRESSION SITE I DO KNOW IT WAS SEEN ON CT SO AT WHAT POINT IT BECAME DISCONNECTED I AM NORE SURE. I AM WAITING TO HEAR FROM PATHOLOGY IF THEY HAVE THE SPECIMEN SINCE IT WAS SENT AS GROSS EXAM ONLY, I WILL LE TYOU KNOW IF WE CAN STILL RETRIEVE IT." WE HAVE INVESTIGATED MANUFACTURING RECORDS AND HAVE DETECTED NO ISSUES. PRODUCTION SAMPLES ARE SUBJECT TO PULL TEST ON THE HUB / CATHETER TO INSURE PROPER ASSEMBLY. THIS PRODUCT HAS BEEN PRODUCED SINCE 2007 AND PRODUCED AT SIGNIFICANT VOLUMES WITH NO FAILURES BETWEEN THE HUB AND CATHETER. DELAY OF FILING REPORT WAS DUE TO THE TIME REQUIRED TO SET UP THE PROTOCOL TO E-FILE AND COMPLETE WEBTRADER PRODUCTION TESTING.

    Description of Event or Problem · 1

    A TENSION PNEUMOTHORAX DECOMPRESSION NEEDLE/CATHETER WAS USED ON A PATIENT IN THE FIELD BY EMS. THE CATHETER BECAME DETACHED FROM THE HUB END AND WAS IN THE PATIENT'S CHEST. SURGERY WAS REQUIRED TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137357 TPAK TENSION PNEUMOTHORAX DECOMPRESSION NEEDLE GAA TYTEK MEDICAL, INC. TM-303 170719C01

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other