BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

    MDR report key: 14875153 · Received June 30, 2022

    Report

    Report Number
    1820334-2022-01135
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Report Date
    September 27, 2022
    Manufacturer
    COOK INC
    Product Code
    JOH
    UDI-DI
    00827002576865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    CORRECTION: D4 (LOT # AND UDI). INVESTIGATION ¿ EVALUATION: IT WAS REPORTED TO COOK THAT A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET (RPN: C-PTIS-100-UNS-HC-G-EU) FROM AN UNKNOWN LOT THAT THE DILATOR IS VERY SMOOTH AND QUICKLY DOUBLE BENDS WHEN DILATING DURING A PERCUTANEOUS TRACHEOSTOMY. THE COMPLAINANT ALSO NOTED THAT THE DILATOR IS LIGHTER IN COLOR, AND IT DOES NOT HAVE A SMOOTH SURFACE LIKE THOSE IN THE PREVIOUS SETS. THIS INCIDENT WAS REPORTED BY (B)(6), IN THE NETHERLANDS, ON 20JUN2022. NO ADVERSE EFFECTS WERE REPORTED. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL, AND INSTRUCTIONS FOR USE (IFU), WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY. HOWEVER, REVIEW OF SALES TO THE COMPLAINANT FROM 01JAN2019 - 20JUN2022 YIELDED ONE LOT NUMBER: 13977183. THE DEVICE HISTORY RECORD (DHR) FOR LOT 13977183 AND RELATED SUB-ASSEMBLY LOTS DID NOT RECORD ANY NON-CONFORMANCES, AND A DATABASE SEARCH REVEALED NO ADDITIONAL COMPLAINTS FOR LOT 13977183 FROM THE FIELD. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, C_T_PTISGI_REV0 ¿BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿PRECAUTIONS ¿ THE TRACHEOSTOMY TUBE SHOULD FIT SNUGLY TO THE LOADING DILATOR FOR INSERTION. ¿ THE GENEROUS LUBRICATION OF THE LOADING DILATOR SURFACE WILL ENHANCE FIT AND PLACEMENT OF THE TRACHEOSTOMY TUBE. INSTRUCTIONS FOR USE (PATIENT PREPARATION) GENEROUSLY LUBRICATE THE SURFACE OF THE APPROPRIATELY SIZED LOADING DILATOR AND LOAD THE TRACHEOSTOMY TUBE INTO THE DILATOR. ENSURE THAT THE TRACHEOSTOMY TUBE¿S TIP FITS SNUGLY ON THE DILATOR. ENSURE THE BALLOON IS COMPLETELY DEFLATED. THOROUGHLY LUBRICATE THE TRACHEOSTOMY TUBE ASSEMBLY. (TRACHEOSTOMY PROCEDURE) 13. ACTIVATE THE HYDROPHILIC COATING BY IMMERSING THE DISTAL END OF THE BLUE RHINO G2 IN STERILE WATER OR SALINE. 18. ADVANCE THE TRACHEOSTOMY TUBE (LOADED ON THE DILATOR) OVER THE WIRE GUIDE/GUIDING CATHETER ASSEMBLY TO THE SAFETY RIDGE OF THE GUIDING CATHETER, THEN ADVANCE WIRE GUIDE, GUIDING CATHETER, LOADING DILATOR AND TRACHEOSTOMY TUBE AS A UNIT INTO TRACHEA." BASED ON THE AVAILABLE INFORMATION, NO DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. 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 AN UNKNOWN PATIENT REQUIRED A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET. THIS REPORT CAPTURES ONE SPECIFIC EVENT, AS WELL AS OTHER UNKNOWN INSTANCES OF THIS FAILURE. THE USER NOTICED THAT THE DILATOR SEEMS "SOFTER AND LIGHTER IN COLOR". IT WAS ALSO STATED THAT IT APPEARED VERY SMOOTH AND IT QUICKLY "DOUBLE NODS" DURING DILATION, "ESPECIALLY IN YOUNGER PATIENTS WHO WERE GIVEN A TRACHEA CANNULA." THE PROCEDURES WERE COMPLETED WITHOUT COMPLICATIONS. AS REPORTED, THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    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
    2301413 BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC N/A 13977183 00827002576865

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TRACOE TWIST TRACHCAN 7 (UNF + CUFF) 470311P7.