BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THAL-QUICK CHEST TUBE SET

    MDR report key: 9538268 · Received January 2, 2020

    Report

    Report Number
    1820334-2020-00015
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 13, 2019
    Report Date
    May 6, 2020
    Manufacturer
    COOK INC
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: A CUSTOMER AT BLACKTOWN HOSPITAL (AUSTRALIA) NOTIFIED COOK THAT THE HUB ON A C-TQTS-1400 (THAL-QUICK CHEST TUBE SET) SEPARATED ON 13DEC2019 AFTER BEING IMPLANTED IN A PATIENT. THE CHEST TUBE HAD BEEN IN PLACE FOR 5 DAYS AND WAS CONNECTED TO A COOK C-TQF-28.0. THE DEVICE WAS SCHEDULED FOR REMOVAL THAT DAY, SO THE CATHETER WAS CLAMPED AND REMOVED. THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS. THE DEVICE WAS DISCARDED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION OF PHOTOS PROVIDED OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED AT THE USER FACILITY. A PHOTO OF THE FAILURE WAS PROVIDED AND SHOWS THE CATHETER TUBING SEPARATED FROM THE HUB. THE TUBING PROXIMAL END IS FLARED. COOK COULD NOT CONFIRM THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION BASED ON THE PROVIDED PHOTO. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD FOUND THAT PROPER PROCEDURES 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 RECORD FOUND NO NONCONFORMANCES OR ADDITIONAL COMPLAINTS ASSOCIATED WITH EITHER OF THE POTENTIAL DEVICE LOTS. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. ADDITIONALLY, A REVIEW OF THE PRODUCT LABELING FOR THE DEVICE WAS COMPLETED. THE INSTRUCTIONS FOR USE STATES TO SUTURE THE CHEST TUBE TO THE SKIN. IT ALSO STATES " UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." A SUPPLIER INVESTIGATION WAS PERFORMED FOR THE RETURNED DEVICE AS THE AFFECTED COMPONENT IS PROVIDED TO COOK FROM AN EXTERNAL SUPPLIER. COOK PREVIOUSLY ISSUED A SCAR. THE SUPPLIER PERFORMED CORRECTIVE ACTIONS RELATED TO DEFECT AWARENESS AND TRAINING, ALONG WITH A VISUAL INSPECTION AND DESTRUCTIVE TENSILE TESTING ON REPRESENTATIVE DEVICES PER THEIR VALIDATED TEST METHODS AND PROCESSES. ALL DEVICES MET THE MINIMUM TENSILE STRENGTH SPECIFICATION. THE SUPPLIER DID NOT FIND A DEFINITIVE ROOT CAUSE FOR THE COMPLAINTS WITHIN THE SCOPE OF THE SCAR, AND NONE OF THE DEVICES HAD AN IDENTIFIABLE MANUFACTURING-RELATED DEFECT CLEARLY LINKED TO FAILURE OF THE DEVICE AT THE BOND. THE DEVICE WAS NOT RETURNED AND COULD NOT BE SENT TO THE SUPPLIER FOR EVALUATION. BASED ON THE SCAR AND REPRESENTATIVE TESTING, THERE IS NO EVIDENCE TO SUGGEST THIS DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE PHOTOS PROVIDED, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE WAS ESTABLISHED AS COMPONENT FAILURE WITHOUT DESIGN OR MANUFACTURING DEFICIENCY. 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

    NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    LOT #: UNSURE, BUT COULD BE 10019902 OR 9991342. (B)(6). PMA/510(K): EXEMPT. 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 THE CATHETER OF A THAL-QUICK CHEST TUBE SET HAD DISCONNECTED FROM THE FLANGE WHILE IN A PATIENT. THE DEVICE WAS INSERTED INTO THE PATIENT FOR DRAINAGE OF PLEURAL EFFUSION. AFTER THE DISCONNECTION, THE CATHETER WAS CLAMPED AND REMOVED. THE HUB WAS CONNECTED TO A COOK THAL-QUICK CHEST TUBE ADAPTER AND WAS IN PLACE FOR 5 DAYS. THERE WERE NO ADVERSE EFFECTS EXPERIENCED AS A RESULT OF THE DISCONNECTED BECAUSE THE EFFUSION HAD CLEARED AND THE CATHETER WAS ALREADY DUE FOR REMOVAL FROM THE PATIENT THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860 THAL-QUICK CHEST TUBE SET GBX CATHETER, IRRIGATION GBX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1