BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 17274303 · Received July 6, 2023

    Report

    Report Number
    1820334-2023-00873
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    May 22, 2023
    Report Date
    December 21, 2023
    Manufacturer
    COOK INC
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4- PMA/510(K) #: K193133. H6- ANNEX E CODE NOT AVAILABLE: ELEVATED PEEK PRESSURES. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. AN ISSUE WAS REPORTED ON (B)(6) 2023 INVOLVING A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY FROM AN UNKNOWN LOT. ON THE DAY OF THE PROCEDURE, A CUFF LEAK WAS NOTED, BUT NO DAMAGE TO THE BALLOON DURING PLACEMENT WAS SUSPECTED. OVER-INFLATION OF THE CUFF WAS UTILIZED OVER THE NEXT FEW DAYS TO IMPROVE THE LEAK, HOWEVER IT PERSISTED. THE PATIENT WENT TO THE OPERATING ROOM FOR A TUBE EXCHANGE (ULTIMATELY TO A 10 MM CUFFED TUBE) WITH BRONCHOSCOPE CONFIRMATION AND HAD NO LEAK. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) WAS COMPLETED. THIS COMPONENT IS SUPPLIED TO COOK AND ADDED DIRECTLY TO THE COOK SET/TRAY/PROCEDURE PACK AND IS NOT MODIFIED IN ANY WAY. COOK DOES NOT HAVE INSPECTIONS FOR THE TRACHEOSTOMY TUBE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED DUE TO THE LACK OF LOT INFORMATION PROVIDED BY THE FACILITY. COOK WAS ALSO ABLE TO REVIEW PRODUCT LABELING. INSTRUCTIONS FOR USE (IFU) DOCUMENT C_T_PTISGI2_REV0 IS PACKAGED WITH THIS DEVICE. THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE: PATIENT PREPARATION: 1. FOLLOWING THE TRACHEOSTOMY TUBE MANUFACTURER¿S INSTRUCTIONS, TEST THE BALLOON CUFF AND INFLATION SYSTEM. 6. GENEROUSLY LUBRICATE THE SURFACE OF THE APPROPRIATELY SIZED LOADING DILATOR AND LOAD THE TRACHEOSTOMY TUBE ONTO THE DILATOR. ENSURE THAT THE TRACHEOSTOMY TUBE¿S TIP FITS SNUGLY ON THE DILATOR. ENSURE THAT THE BALLOON IS COMPLETELY DEFLATED. THOROUGHLY LUBRICATE TRACHEOSTOMY TUBE ASSEMBLY. TRACHEOSTOMY PROCEDURE: 20. INFLATE THE TRACHEOSTOMY TUBE BALLOON CUFF. CONNECT THE TRACHEOSTOMY TUBE TO THE VENTILATOR. CONFIRM POSITION OF THE TRACHEOSTOMY TUBE VIA STANDARD METHODS (E.G., CAPNOGRAPHY, BREATH SOUNDS, ETC.). 21. DEFLATE AND REMOVE THE ENDOTRACHEAL TUBE. POST-PLACEMENT: FOLLOW HOSPITAL PROTOCOL FOR POST-TRACHEOSTOMY CARE AND MAINTENANCE. EVIDENCE GATHERED UPON REVIEW OF THE INFORMATION PROVIDED, THE DMR, AND THE IFU SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS DETERMINED THAT AN UNINTENDED USER ERROR CONTRIBUTED TO THE EVENT. SEVERAL SIZES AND STYLES OF TRACHEOSTOMY TUBES (6 MM CUFFED, 6 MM CUFFED XLT, DISTAL 6 MM CUFFED XLT, 8 MM CUFFED) WERE PLACED PRIOR TO THE TRACHEOSTOMY TUBE THAT ULTIMATELY DID NOT LEAK, A 10 MM CUFFED TUBE. BASED ON THIS INFORMATION, IT IS LIKELY THAT PATIENT ANATOMY AND IMPROPER SIZING OF THE TRACHEOSTOMY TUBE CONTRIBUTED TO THIS INCIDENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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

    AS REPORTED IN A RETROSPECTIVE, POST MARKET STUDY, THE TRACHEOSTOMY TUBE FROM A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY REQUIRED REPLACEMENT IN A 70-YEAR-OLD, MALE PATIENT. ON (B)(6) 2023, A TRACHEOSTOMY PROCEDURE WAS PERFORMED IN THE INTENSIVE CARE UNIT DUE TO PROLONGED VENTILATORY SUPPORT AND DECREASED MENTAL STATUS RELATED TO A HISTORY OF TBI (TRAUMATIC BRAIN INJURY). THE PATIENT WAS INTUBATED. THE PATIENT'S POSITIVE END-EXPIRATORY PRESSURE (PEEP) WAS LESS THAN 20. ULTRASOUND WAS NOT USED. DURING THE PROCEDURE, BRONCHOSCOPIC GUIDANCE WAS USED. A HORIZONTAL INCISION WAS MADE AND BLUNT DISSECTION WAS PERFORMED. PERCUTANEOUS DILATION AND INSERTION OF THE TRACHEOSTOMY TUBE ON THE FIRST ATTEMPT WERE SUCCESSFUL. THE TRACHEOSTOMY TUBE WAS PLACED EASILY, AND NO DAMAGE TO THE BALLOON WAS SUSPECTED. POST-PROCEDURAL CHEST X-RAY WAS ORDERED TO EVALUATE PLACEMENT OF TRACHEOSTOMY TUBE AND ENSURE NO DEVELOPMENT OF A PNEUMOTHORAX. ON THE DAY OF THE PROCEDURE, A CUFF LEAK WAS NOTED. THE BALLOON WAS OVER INFLATED TO A PRESSURE OF 60 MMHG AND THE LEAK IMPROVED. ON (B)(6) 2023, THE BALLOON CUFF WAS INSUFFLATED TO 80 MMHG TO AVOID LEAK. THEN, USING A BOUGIE, THE PERCUTANEOUS TRACHEOSTOMY WAS REMOVED, AND A 6 CUFFED SHILEY TRACHEOSTOMY TUBE WAS INSERTED. A BRONCHOSCOPE WAS INSERTED WHICH CONFIRMED ADEQUATE PLACEMENT. THE PATIENT HAD ADEQUATE END-TIDAL CO2'S, BUT THE CUFF CONTINUED TO LEAK DESPITE INSUFFLATED BALLOON. THEY ELECTED TO EXCHANGE THE TRACHEOSTOMY TUBE FOR A DISTAL 6 CUFFED XLT. THE LEAK CONTINUED, SO IT WAS EXCHANGED FOR AN 8 CUFFED TRACHEOSTOMY. THE LEAK CONTINUED AND THE PATIENT WAS EXPERIENCING HIGH PEAK PRESSURES, SO A 10 CUFFED SHILEY TRACH WAS PLACED. WITH THE 10 CUFFED TUBE, THE PATIENT'S PEAK PRESSURES IMPROVED AND THE CUFF HAD NO LEAK. AS REPORTED, THE EVENT RESOLVED ON (B)(6) 2023 WITHOUT ANY FURTHER INCIDENCE OR ADVERSE EFFECTS FOR THE PATIENT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031672 BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention