BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 17221198 · Received June 28, 2023

    Report

    Report Number
    1820334-2023-00842
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    June 6, 2021
    Report Date
    July 14, 2023
    Manufacturer
    COOK INC
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, IT WAS DETERMINED 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. ALTHOUGH BLEEDING AND IRRITATION WERE REPORTED, THERE WAS NO INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR DEATH. IT WAS REPORTED THAT A BRONCHOSCOPY WAS PERFORMED AND THE PATIENT COUGHED UP A BLOOD CLOT; HOWEVER, THERE IS NO INDICATION THAT THE BRONCHOSCOPY WAS PERFORMED DUE TO THE BLEEDING. THERE WAS NO INTERVENTION PERFORMED RELATED TO THE EXPECTORATED BLOOD CLOT. IT WAS REPORTED THAT THE EVENT RESOLVED WITHOUT SEQUELA. IT WAS NOTED THE EVENT WAS NOT RELATED TO THE DEVICE. THEREFORE, THIS EVENT IS NO LONGER CONSIDERED A SERIOUS INJURY PER 21 CFR PART 803.3. THERE IS ALSO NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF A COOK DEVICE. AS SUCH, THIS EVENT WILL BE CLOSE/CANCELED BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. A3 - AGE: THE PATIENT WAS 35-YEARS-OLD AT THE TIME OF THE PROCEDURE. E3 - OCCUPATION: PRINCIPAL INVESTIGATOR. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT EXPERIENCED A HEMORRHAGE FOLLOWING PLACEMENT OF A TRACHEOSTOMY TUBE USING A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY. THE PROCEDURE WAS PERFORMED ON (B)(6) 2021 IN THE INTENSIVE CARE UNIT (ICU) DUE TO PROLONGED VENTILATORY SUPPORT AND RESPIRATORY INSUFFICIENCY FROM A TRAUMATIC BRAIN INJURY. THE PATIENT WAS INTUBATED, AND POSITIVE END-EXPIRATORY PRESSURE (PEEP) WAS LESS THAN 20. ULTRASOUND WAS NOT USED. DURING THE PROCEDURE, BRONCHOSCOPIC GUIDANCE WAS USED. A VERTICAL INCISION WAS MADE, AND BLUNT DISSECTION WAS PERFORMED. PERCUTANEOUS DILATION WAS SUCCESSFUL, AND THE TRACHEOSTOMY TUBE WAS ABLE TO BE PLACED ON THE FIRST ATTEMPT. NO ADVERSE EVENTS OR DEVICE DEFICIENCIES WERE IDENTIFIED DURING THE PROCEDURE. ON (B)(6) 2021 (2 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED A HEMORRHAGE. TRACHEAL IRRITATION AND BLEEDING WERE OBSERVED AROUND THE TRACH SITE. DURING THE BRONCHOSCOPY THAT FOLLOWED, THE PATIENT EXPECTORATED A BLOOD CLOT. PATIENT HEMORRHAGE ENDED ON THE SAME DAY AND RESOLVED WITHOUT SEQUELAE. THE STUDY SITE CONSIDERED THE EVENT TO BE RELATED TO THE SURGICAL PROCEDURE AND NOTED, "BLEEDING FROM THE SURGICAL INCISION.¿ IT WAS CONSIDERED THAT THE EVENT WAS NOT DUE TO A DEVICE DEFICIENCY. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150610 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 35 YR Female Required Intervention