BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

    MDR report key: 16299008 · Received February 3, 2023

    Report

    Report Number
    1820334-2023-00096
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 24, 2023
    Report Date
    May 4, 2023
    Manufacturer
    COOK INC
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. 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

    CORRECTED INFORMATION: UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THIS EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY OR REPORTABLE PRODUCT MALFUNCTION. THE INFORMATION WITHIN THIS COMPLAINT WAS DETERMINED TO BE CUSTOMER FEEDBACK ON THE DEVICE RATHER THAN AN ADVERSE EVENT INVOLVING A PRODUCT MALFUNCTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUNCH DILATOR IN BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SETS ARE LONGER AND "LESS STIFF OR RESILIENT." THIS COMPLAINT WAS MADE REGARDING DISSATISFACTION WITH A GENERAL FEATURE OF THIS DEVICE. THE REPORTING PHYSICIAN CLAIMS THE 14 FRENCH PUNCH DILATOR IS LONGER IN THE NEWER G2 MULTI-SETS MAKING THE PRODUCT LESS STIFF OR RESILIENT. THIS CREATES A RISK OF PUSHING THE DILATOR INTO THE AIRWAY TOO FAR AND MAKING THE WIRE GUIDE MORE PRONE TO BEND AND KINK. BECAUSE OF THIS, THE PHYSICIAN'S ENTRY HAS TO BE ADJUSTED. IT SHOULD BE NOTED THAT THERE WAS NO SPECIFIC DEVICE LOT FAILURE. NO PATIENT HARMS OR ADVERSE EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225869 BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown