BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THAL-QUICK CHEST TUBE TRAY

    MDR report key: 4947092 · Received July 22, 2015

    Report

    Report Number
    1820334-2015-00470
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 29, 2015
    Manufacturer
    COOK, INC.
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION/EVALUATION: DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, QUALITY CONTROL, TRENDS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND DRAWING WAS CONDUCTED. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. THE DEVICE IS PACKAGED WITH IFU. THE IFU GIVES THE DEVICE DESCRIPTION, INTENDED USE, WARNINGS, PRECAUTIONS AND INSTRUCTIONS FOR PLACEMENT AND USE OF THE DEVICE. WITHOUT THE RETURN OF THE COMPLAINT DEVICE OR PRODUCT INFORMATION TO EXAMINE PRODUCTION RECORDS, THE ROOT CAUSE OF THIS COMPLAINT IS INCONCLUSIVE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. WE HAVE NOTIFIED APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A WAYNE PNEUMOTHORAX TUBE WAS PLACED AT 8CM INSIDE THE PATIENT. ON (B)(6) 2015 THE DEVICE WAS NOTED TO BE OUT OF PLEURAL SPACE VIA CT SCAN (MDR#1820334-2015-00454) AND A THAI-QUICK CHEST TUBE WAS PLACED. ON (B)(6) 2015, IT WAS NOTED THE THAI-QUICK WAS OUT OF PLACE VIA CT SCAN (1820334-2015-00470) AND A MULTIPURPOSE DRAINAGE CATHETER WAS PLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A WAYNE PNEUMOTHORAX TUBE WAS PLACED AT 8CM INSIDE THE PATIENT. ON (B)(6) 2015 THE DEVICE WAS NOTED TO BE OUT OF PLEURAL SPACE VIA CT SCAN (MDR# 1820334-2015-00454) AND A THAL-QUICK CHEST TUBE WAS PLACED. ON (B)(6) 2015, IT WAS NOTED THE THAL-QUICK WAS OUT OF PLACE VIA CT SCAN (1820334-2015-00470) AND A MULTIPURPOSE DRAINAGE CATHETER WAS PLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474207 THAL-QUICK CHEST TUBE TRAY GBX CATHETER, IRRIGATION GBX COOK, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Required Intervention