BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 12642652 · Received October 15, 2021

    Report

    Report Number
    1820334-2021-02340
    Event Type
    Injury
    Date Received
    October 15, 2021
    Report Date
    August 10, 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

    INVESTIGATION ¿ EVALUATION: DR. (B)(6) FROM (B)(6) CONTACTED COOK ON 06OCT2021 REGARDING A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY (C-PTISY-100-HC-G-NA-FLEX8.5, LOT: UNKNOWN). THEY REPORTED A SHILEY CUFF LEAK THAT DEVELOPED ON POST OPERATIVE DAY 18. THE CUSTOMER STATES THAT THEY FEEL THE TAPER GUARD CUFF IS POORLY SHAPED AND NOT GETTING ENOUGH ¿PURCHASE¿ ON THE TRACHEA. THE CUSTOMER STATES THAT WHEN THEY START WITH AN 8.5 CUFF THEN SWITCH TO AN 8 THERE IS STILL A NOTED AIR LEAK, WHEN JUST STARTING WITH AN 8 IS NORMALLY NOT SEEN. THE PATIENT DID REQUIRE A PERCUTANEOUS TRACHEOSTOMY TO REPLACE THE TRACHEOSTOMY TUBE. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. THE SHILEY TRACH TUBE IS A PRODUCT WHICH COOK PURCHASES AND PLACES IN THIS SUPER-SET. COOK DOES NOT HAVE ANY INSPECTIONS FOR THIS PRODUCT. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER TO AID IN THE INVESTIGATION. A SALES REPORT WAS PERFORMED TO DETERMINE A POSSIBLE LOT NUMBER. COOK WAS NOT ABLE TO DETERMINE THE LOT NUMBER DUE TO THE AMOUNT OF POSSIBLE LOT NUMBERS FOR THIS CUSTOMER. BASED ON THE LIMITED INFORMATION COOK HAS, COOK WAS NOT ABLE TO DETERMINE THE PRODUCT OUT OF SPECIFICATION. COOK WAS NOT ABLE TO DETERMINE NON-CONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK 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 INFORMATION PROVIDED, NO DEVICE INSPECTION, AND THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 (B)(6) 2022. 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 THE PATIENT AND/OR EVENT 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 18 DAYS POST-OPERATIVE. 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
    1541554 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