BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THAL-QUICK CHEST TUBE SET

    MDR report key: 2133705 · Received June 9, 2011

    Report

    Report Number
    1820334-2011-00290
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 16, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ADDITIONAL SURGICAL PROCEDURES ARE NOT LABELED IN THE IFU. (B)(4) FITTING SEPARATION IS NOT LABELED IN THE IFU. THE DEVICE WAS RETURNED TO ASSIST IN THIS INVESTIGATION. EACH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) DESCRIBES THE APPROPRIATE WARNINGS, PRECAUTIONS AND PLACEMENT TECHNIQUES. THERE IS A 100% VERIFICATION OF THE SECURITY OF THE FITTING OF THE TUBING VIA A MANUAL TUG. (B)(4). APPROPRIATE DESIGN CONTROL ACTIVITIES HAVE BEEN COMPLETED. THE COMPLAINT DEVICE WAS RETURNED IN A USED AND CONTAMINATED CONDITION. THE CONICAL HUB WAS CONFIRMED TO BE SEPARATED FROM THE SEVERELY KINKED SHAFT. IT IS POSSIBLE THAT THE CATHETER WAS EXPOSED TO FORCES ABOVE WHAT WOULD BE EXPECTED UNDER TYPICAL CIRCUMSTANCES. THE SUPPLIER WILL BE NOTIFIED OF THIS EVENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL. THE QUALITY ENGINEERING RISK ASSESSMENT (QERA) WAS REVIEWED AND NO FURTHER MITIGATING ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    PRODUCT WAS INSERTED INTO CUSTOMER AS USUAL AND WHEN RETRACTING THE PRODUCT THE CANNULA STAYED INSIDE THE PATIENT. THE PHYSICIAN PLACED THE TQTS WITH SONOGRAPHIC- SUPPORT AND EVERYTHING WAS OK. THE PATIENT HAD AN 1,2I PLEURAL EFFUSION THAT WAS DRAINED. DURING STITCHING THE TQTS, THE PHYSICIANS NOTICED THAT THE DRAINAGE STARTING WITH FISTULAS AND NOBODY SAW SUCH A THING BEFORE. THE PHYSICIANS INSPECTED THE DRAINAGE AND NOTICED THAT THE END OF THE TQTS (=ADAPTER) WAS DISCONNECTED WITH THE REST OF THE DRAINAGE. THE REST OF THE DRAINAGE DISPLACED AND THE IMMEDIATE SKINCUTTING TO GET THE DRAINAGE WASN'T SUCCESSFUL. THE RESULT WAS THAT THE PATIENT GOT A MINITHORACOTOMY, (SURGERY) THE NEXT DAY. YES, SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE END OF THE DRAINAGE DISCONNECTED SO THAT THE SLIP PART DISPLACED. THE DISPLACED PART WAS REMOVED WITH A MINITHORACOTOMY (SURGERY). THE ADDITIONAL PROCEDURES WERE BECAUSE OF THE SURGERY TO REMOVE THE PART OF THE DRAINAGE, THE PATIENT HAD TO INTUBATE LONGER THAN IT WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THAL-QUICK CHEST TUBE SET DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA F2478000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention