BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 12642850 · Received October 15, 2021

    Report

    Report Number
    1820334-2021-02341
    Event Type
    Injury
    Date Received
    October 15, 2021
    Report Date
    August 4, 2022
    Manufacturer
    COOK INC
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 ¿ 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. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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 (B)(6) HOSPITAL (UNITED STATES) CONTACTED COOK ON (B)(6) 2021 TO REPORT THAT WHEN USING THE SHILEY CUFF FROM AN UNKNOWN BLU RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY (LOT UNKNOWN) DURING A PERCUTANEOUS TRACHEOSTOMY, AIR LEAKAGE WAS NOTED. THE CUSTOMER STATES THAT THEY FEEL THE TAPER GUARD CUFF IS POORLY SHAPED AND NOT GETTING ENOUGH ¿PURCHASE¿ ON THE TRACHEA. THE CUSTOMER ALSO STATED THAT WHEN THEY START WITH AN 8.5 CUFF AND SWITCH TO AN 8, THERE IS STILL A NOTED AIR LEAK. WHEN JUST STARTING WITH AN 8, A LEAK IS NORMALLY NOT SEEN. THE ONLY ADVERSE EFFECT TO THE PATIENT WAS A NEED FOR TRACH REPLACEMENT. A REVIEW OF THE DOCUMENTATION, INCLUDING THE INSTRUCTIONS FOR USE (IFU) OF THE DEVICE, WAS 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) COULD NOT BE CONDUCTED, AS THE SHILEY TRACH TUBE IS A MEDTRONIC/COVIDIEN PRODUCT THAT IS PURCHASED BY COOK TO BE INCLUDED IN THIS SUPER SET. COOK DOES NOT HAVE ANY INSPECTION INFORMATION FOR THIS PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED DUE TO THE LACK OF LOT INFORMATION PROVIDED BY THE FACILITY. BASED ON THE LIMITED INFORMATION, COOK WAS NOT ABLE TO DETERMINE THE PRODUCT OUT OF SPECIFICATION, OR IF NONCONFORMING MATERIAL EXISTS IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THIS KIT IS SUPPLIED WITH A COOK INSTRUCTIONS FOR USE (IFU) PAMPHLET C_T_PTISGI2_REV0. THERE IS NO IFU FOR THE SHILEY TRACH TUBE. THE COOK IFU STATES IN THE PRECAUTIONS SECTION: THE TRACHEOSTOMY SHOULD FIT SNUGLY TO THE LOADING DILATOR. THE GENEROUS LUBRICATION OF THE LOADING DILATOR SURFACE WILL ENHANCE FIT AND PLACEMENT OF THE TRACHEOSTOMY TUBE. TRACHEOSTOMY TUBE POSITION SHOULD BE VERIFIED BY A CHEST X-RAY. IN THE INSTRUCTIONS FOR USE SECTION, IT STATES: 1) FOLLOWING THE TRACHEOSTOMY TUBE MANUFACTURER¿S INSTRUCTIONS, TEST THE BALLOON CUFF AND INFLATION SYSTEM. IN THE HOW SUPPLIED SECTION IT STATES: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE LIMITED INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE ESTABLISHED. 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

    ADDITIONAL INFORMATION WAS PROVIDED ON 10JAN2022. THE PATIENT WAS DESCRIBED AS BEING ON HIGH PEAK AIRWAY PRESSURE (AROUND 45). CARE FOR THE TUBE WAS DESCRIBED AS SUCTIONING AS NEEDED. THE TRACH WAS SUTURED IN LOOSELY WITH 2 SUTURES AND HELD IN PLACE WITH TRACH STRAPS. THE ONLY ADVERSE EVENT IS A NEED FOR TRACH REPLACEMENT. ADDITIONALLY, IT WAS PROVIDED THAT THIS EVENT IS "SIMILAR" TO THAT OF THE INCIDENT REPORTED UNDER MEDWATCH REPORT #:1820334-2022-00092.

    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.

    Additional Manufacturer Narrative · 1

    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 CUFF OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY SLOWLY LEAKED FROM THE VALVE FOUR DAYS POST-OPERATIVE, REQUIRING "HIGHER FILLING PRESSURES." ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541560 BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention