BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 13343985 · Received January 25, 2022

    Report

    Report Number
    1820334-2022-00112
    Event Type
    Injury
    Date Received
    January 25, 2022
    Report Date
    October 24, 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

    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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED 10JAN2022 BY TEJVEER DHILLON OF RIDEOUT MEMORIAL HOSPITAL (UNITED STATES) THAT THE TRACHEOSTOMY CUFF IN A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY (RPN: C-PTISY-100-HC-G-NA-FLEX8.5, LOT: UNKNOWN) LEAKED. NO SPECIFIC DETAILS WERE PROVIDED FOR THIS EVENT. THE PHYSICIAN STATED THIS EVENT IS SIMILAR TO ANOTHER REPORTED EVENT (MEDWATCH #:1820334-2022-00092). THEREFORE, IN THIS EVENT, IT IS PRESUMED THE PHYSICIAN SECURED THE COMPLAINT TRACHEOSTOMY DEVICE LOOSELY WITH 2 SUTURES AND TRACHEOSTOMY STRAPS. LATER, A LEAK IN THE TRACHEOSTOMY CUFF WAS DISCOVERED. 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. AS A RESULT, THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE WITH SEDATION AND PARALYSIS TO REPLACE THE DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS PATIENT. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. THE SHILEY TRACH TUBE IS PURCHASED AND PLACED IN THE 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 WAS NOT ABLE TO DETERMINE IF THE PRODUCT OUT OF SPECIFICATION. COOK WAS NOT ABLE TO DETERMINE NON-CONFORMING MATERIAL 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. "PRECAUTIONS: 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. INSTRUCTIONS FOR USE: PATIENT PREPARATION: 1. FOLLOWING THE TRACHEOSTOMY TUBE MANUFACTURER¿S INSTRUCTIONS, TEST THE BALLOON CUFF AND INFLATION SYSTEM. 6. GENEROUSLY LUBRICATE THE SURFACE OF THE APPROPRIATELY SIZED LOADING DILATOR AND LOAD THE TRACHEOSTOMY TUBE ONTO THE DILATOR. ENSURE THAT THE TRACHEOSTOMY TUBE¿S TIP FITS SNUGLY ON THE DILATOR. ENSURE THAT THE BALLOON IS COMPLETELY DEFLATED. THOROUGHLY LUBRICATE TRACHEOSTOMY TUBE ASSEMBLY POST-PLACEMENT: FOLLOW HOSPITAL PROTOCOL FOR POST-TRACHEOSTOMY CARE AND MAINTENANCE. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED, NO RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED 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

    IT WAS REPORTED THE CUFF OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY LEAKED. THE TRACHEOSTOMY TUBE WAS SUTURED LOOSELY WITH TWO SUTURES AND HELD IN PLACE WITH TRACHEOSTOMY TUBE STRAPS. TRACHEOSTOMY TUBE CARE INCLUDED SUCTIONING AS NEEDED. THE TRACHEOSTOMY TUBE WAS REMOVED AND REPLACED. NO OTHER ADVERSE EFFECTS WERE REPORTED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614189 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