BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
Report
- Report Number
- 1820334-2025-00059
- Event Type
- Malfunction
- Date Received
- January 15, 2025
- Report Date
- August 26, 2025
- Manufacturer
- COOK INC
- Product Code
- JOH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. CORRECTION: H6 - ANNEX G. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT THE CUFF OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY EXPERIENCED LEAKAGE FOLLOWING PLACEMENT IN AN UNKNOWN PATIENT. THE THORACIC SURGEONS STARTED PERFORMING THE PERCUTANEOUS TRACHEOSTOMIES IN THE OPERATING ROOM. CURRENTLY, THE FACILITY HAS STOCKED ONLY THE INTRODUCER TRAY WITH THE SMALLER TRACHEOSTOMY TUBE. HOWEVER, IN TWO RECENT INSTANCES, THIS INTRODUCER WAS USED WITH THE LARGER TRACHEOSTOMY TUBE, LEADING TO THE AIR LEAKAGE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE CURRENTLY IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICES. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS ABLE TO IDENTIFY THREE POSSIBLE LOTS. COOK REVIEWED THE DHR FOR THE THREE FINAL LOTS AND RECORDS NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THE THREE LOTS FOUND NO COMPLAINTS REPORTED FORM 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 THE FIELD COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU [C_T_PRISGI2_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: ¿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 INTO THE DILATOR. ENSURE THAT THE TRACHEOSTOMY TUBE¿S TIP FITS SNUGLY ON THE DILATOR. 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 INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK WAS UNABLE TO ESTABLISH A CAUSE FOR THIS FAILURE. IT IS UNKNOWN IF THERE WAS LEAKAGE BETWEEN THE TRACHEOSTOMY TUBE AND THE LOADING DILATOR OR IF THE CUFF WAS LEAKING. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.
IT WAS REPORTED THAT THE CUFF OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY EXPERIENCED LEAKAGE FOLLOWING PLACEMENT IN AN UNKNOWN PATIENT. THE THORACIC SURGEONS STARTED PERFORMING THE PERCUTANEOUS TRACHEOSTOMIES IN THE OPERATING ROOM. CURRENTLY, THE FACILITY HAS STOCKED ONLY THE INTRODUCER TRAY WITH THE SMALLER TRACHEOSTOMY TUBE. HOWEVER, IN TWO RECENT INSTANCES, THIS INTRODUCER WAS USED WITH THE LARGER TRACHEOSTOMY TUBE, LEADING TO THE AIR LEAKAGE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
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 |
|---|---|---|---|---|---|---|---|
| 1274598 | BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY | JOH TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | COOK INC | G57716 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |