BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THAL-QUICK CHEST TUBE SET

    MDR report key: 9198610 · Received October 16, 2019

    Report

    Report Number
    1820334-2019-02622
    Event Type
    Injury
    Date Received
    October 16, 2019
    Date of Event
    September 29, 2019
    Report Date
    December 11, 2019
    Manufacturer
    COOK INC
    Product Code
    GBX
    UDI-DI
    00827002051614
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D10 - PRODUCT RECEIVED ON, D11. D11 - CONCOMITANT PRODUCTS: ATRIUM OASIS DRY SUCTION WATER SEAL CHEST DRAIN . H6 - METHOD CODE: HISTORICAL DATA ANALYSIS (4109); COMMUNICATION/INTERVIEWS (4111); ANALYSIS OF PRODUCTION RECORDS (3331). INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE, INSPECTION OF UNUSED PRODUCT, AND AN INTERVIEW OF PERSONNEL WERE CONDUCTED DURING THE INVESTIGATION. ONE USED, DAMAGED CHEST TUBE WAS RETURNED TO COOK FOR INVESTIGATION. THE VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE ADAPTER HUB WAS SEPARATED FROM THE CHEST TUBING. THERE WAS A STICKY SUBSTANCE ON THE ADAPTER HUB AND A STRING WAS TIED AROUND IT. NO SURFACE DAMAGE TO THE DEVICE WAS NOTED. A DIMENSIONAL ANALYSIS OF THE CHEST TUBING DEMONSTRATED THAT IT WAS SLIGHTLY OUT OF ROUND AND COULD NOT BE ADEQUATELY COMPARED TO THE DEVICE SPECIFICATIONS AND TOLERANCES, BUT THE ADAPTER HUB WAS WITHIN THE CORRECT SPECIFICATIONS. ADDITIONALLY, 24 UNUSED DEVICES FROM 6 DIFFERENT LOTS (QUANTITY 6 FROM LOT 9902886 AND QUANTITY 18 FROM LOTS 9910446, 9910446, 9854290, 9916520, AND 9910445) WERE RETURNED AND SENT TO THE SUPPLIER FOR INSPECTION. COOK CONFIRMED THAT THE COMPLAINT DEVICE AND THE ADDITIONAL RETURNED UNUSED DEVICES WERE MANUFACTURED WITHIN SPECIFICATION. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD FOUND THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY AND PREVENT THIS FAILURE MODE PRIOR TO DEVICE DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE FOUND THAT THE RISKS ASSOCIATED WITH THE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINT LOT 9902886, ALL ASSEMBLY AND SUBASSEMBLY LOTS REVEALED NO NONCONFORMANCES. A COMPLAINT SEARCH REVEALED NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS DEVICE LOT. A NONCONFORMANCE AND COMPLAINT SEARCH WAS COMPLETED FOR THE 5 ADDITIONAL LOTS (9910446, 9910446, 9854290, 9916520, AND 9910445) OF 18 UNUSED PRODUCT RETURNED AND THERE HAVE BEEN NO OTHER COMPLAINTS OR NONCONFORMANCES REPORTED FOR THESE LOTS. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. A REVIEW OF THE PRODUCT LABELING FOR THE DEVICE WAS COMPLETED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING INSTRUCTIONS RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: "THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN PERCUTANEOUS PLEURAL DRAINAGE TECHNIQUES. STANDARD TECHNIQUES FOR PLACEMENT OF CHEST TUBES SHOULD BE EMPLOYED." INSTRUCTIONS FOR USE; "9. WITH THE WIRE GUIDE STILL POSITIONED WITHIN THE PLEURAL SPACE, ADVANCE THE CHEST TUBE INSERTER/CHEST TUBE ASSEMBLY OVER THE WIRE GUIDE AND INTO THE PLEURAL SPACE. NOTE: IF RESISTANCE IS ENCOUNTERED DURING CHEST TUBE ASSEMBLY INSERTION, DETERMINE THE CAUSE OF RESISTANCE AND TAKE NECESSARY ACTION TO RELIVE RESISTANCE BEFORE PROCEEDING. 11. THE CHEST TUBE CAN NOW BE SUTURED TO THE SKIN AND IS READY FOR USE." HOW SUPPLIED: "UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." THE AFFECTED COMPONENTS ARE SUPPLIED TO COOK BY AN EXTERNAL SUPPLIER. A SUPPLIER INVESTIGATION WAS REQUESTED FOR THE RETURNED DEVICE. VISUAL INSPECTION AND DESTRUCTIVE TENSILE TESTING WERE PERFORMED ON REPRESENTATIVE DEVICES AS WELL AS THE 24 UNUSED DEVICES RETURNED UNDER THIS COMPLAINT. ALL DEVICES MET THE MINIMUM TENSILE STRENGTH SPECIFICATION. BASED ON THIS TESTING, THERE IS NO EVIDENCE TO SUGGEST THE DEVICES WERE MANUFACTURED OUT OF SPECIFICATION. IT IS POSSIBLE THAT PATIENT ACTIVITY OR CLINICAL USE COULD HAVE CONTRIBUTED TO THIS FAILURE MODE BUT THIS COULD NOT BE CONFIRMED. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE WAS ESTABLISHED AS COMPONENT FAILURE WITHOUT A DESIGN OR MANUFACTURING ISSUE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ON 12NOV2019, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DEVICE WAS CONNECTED TO ANOTHER MANUFACTURER'S DRY SUCTION WATER SEAL CHEST DRAIN AT THE TIME OF THE INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510(K) #: EXEMPT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTRODUCTION OF A 12 FRENCH THAL-QUICK CHEST TUBE ON THE LEFT SIDE OF THE PATIENT, "A DISCONNECTION OCCURRED BETWEEN THE CONNECTION FUNNEL CONE OF THE DRAINAGE AND THE DRAINAGE TUBE". THE DISLOCATION OF THE TUBE INTO THE INTRA-THORACIC PART OF THE BODY WENT UNNOTICED, BUT SEEMED TO BE DUE TO SUCTION CAUSED BY PATIENT INSPIRATION. THE SEPARATED PIECE WAS VERIFIED BY AN INTRA-THORACIC X-RAY, AND HAD TO BE RECOVERED BY VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) ON THE LEFT SIDE ON (B)(6) 2019. ADDITIONAL DETAILS REPORTED THE SEPARATION OF THE DEVICE OCCURRED AFTER THE DEVICE WAS FULLY INSERTED INTO THE PATIENT. THE DEVICE WAS SUTURED TO THE PATIENT BY A "TOBACCO BAG SEAM". THE DRAINAGE WAS PLACED ON (B)(6) 2019 AND THE SEPARATION WAS NOTICED ON (B)(6) 2019. THE SECONDARY SURGERY PERFORMED ON (B)(6) 2019 WAS "NORMAL". IT WAS REPORTED THE PATIENT HAS "DELIR", WHICH CAN BE TRANSLATED AS DELIRIUM, A STATE OF SEVERE CONFUSION. THE OTHER DRAIN PLACED ON THE RIGHT SIDE ON (B)(6) 2019 IS STILL IN THE PATIENT WITH NO ISSUES REPORTED. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992437 THAL-QUICK CHEST TUBE SET GBX CATHETER, IRRIGATION GBX COOK INC N/A 9902886 00827002051614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention