BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 16483157 · Received March 3, 2023

    Report

    Report Number
    1820334-2023-00221
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    September 14, 2022
    Report Date
    May 12, 2023
    Manufacturer
    COOK INC
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K193133. 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

    INVESTIGATION ¿ EVALUATION: IT WAS REPORTED BY (B)(6) HOSPITAL ¿ SOUTH (USA) THAT ON (B)(6) 2022, THE TRACHEOSTOMY TUBE SUPPLIED WITH A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY (RPN: C-PTISY-100-HC-G-NA-FLEX8.5; LOT#: UNKNOWN) WAS UNABLE TO ACHIEVE ADEQUATE SEAL. THE DEVICE WAS REQUIRED FOR AN UNKNOWN ¿LARGER¿ PATIENT. AFTER PLACING THE TRACHEOSTOMY TUBE (MEDTRONIC, RPN: 8CN85H), SUPPLIED WITH THE COOK BLUE RHINO, IT WAS DISCOVERED THAT THE BALLOON WAS NOT SEALING PROPERLY IN THE LARGER PATIENT. AS A RESULT, INTERVENTION WAS REQUIRED TO EXCHANGE THE TRACHEOSTOMY TUBE AT THE BEDSIDE IN THE ICU. NO OTHER ADVERSE EVENTS WERE REPORTED FOR THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES 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) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE PRIOR TO DISTRIBUTION. AS THE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE SALES HISTORY OF THIS CUSTOMER FOR THE LAST THREE YEARS WAS ABLE TO IDENTIFY THREE POSSIBLE LOTS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THESE LOTS FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THESE LOT NUMBERS. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [C_T_PTISGI2_REV0] ¿BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: ¿ANATOMIC ANOMALIES MAY MAKE THE PROCEDURE DIFFICULT TO PERFORM.¿ PRECUATIONS: ¿AN ULTRASOUND EVALUATION OF THE PATIENT¿S NECK PRIOR TO THE PROCEDURE MAY AID IN IDENTIFICATION OF ANATOMICAL VARIANCES.¿ "PRODUCT RECOMMENDATIONS: COMPATIBILITY TESTING WAS PERFORMED WITH SHILEY¿ FLEX AND SHILEY¿ EVAC TRACHEOSTOMY TUBES. WHEN USING ANOTHER APPROPRIATELY SIZED TRACHEOSTOMY TUBE, ENSURE THAT THE TRACHEOSTOMY TUBE¿S TIP FITS SNUGLY ON THE DILATOR.¿ "INSTRUCTIONS FOR USE: 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.)." EVIDENCE GATHERED FROM A REVIEW OF THE DMR, IFU, AND DHR SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF 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, COOK CONCLUDES THAT THE CAUSE OF THIS EVENT IS TRACED TO THE USER, AS THE ISSUE WOULD HAVE REQUIRED THE CUSTOMER TO SIZE UP TO A LARGER TUBE SIZE. THE CUSTOMER STATES THE BALLOON¿S SEALING ISSUE IS ONLY NOTICED IN LARGER PATIENTS. 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

    THE COOK BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY THAT INCLUDED ANOTHER MANUFACTURER'S 8.5 TRACHEOSTOMY TUBE WAS USED FOR SEVERAL "EDT PROCEDURES" FROM SEPTEMBER 2021 TO OCTOBER 2022. POST INITIAL PROCEDURE, THE PATIENTS WERE MOVED TO THE INTENSIVE CARE UNIT (ICU). IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE DID NOT SEAL WELL IN THE "LARGER OBESE" PATIENTS AND REQUIRED THE TRACHEOSTOMY TUBE TO BE REMOVED AND REPLACED AT BEDSIDE. NO ADDITIONAL HOSPITALIZATION OR ADVERSE EFFECTS TO THE PATIENTS WERE REPORTED DUE TO THIS OCCURRENCE. THE FOCUS OF THIS REPORT IS THE PATIENT WHO REQUIRED THE REMOVAL AND REPLACEMENT OF THE 8.5 TRACHEOSTOMY TUBE DUE TO INADEQUATE SEAL ON (B)(6) 2022.

    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
    1826231 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 Unknown Required Intervention