BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
Report
- Report Number
- 1820334-2022-00553
- Event Type
- Malfunction
- Date Received
- April 11, 2022
- Report Date
- August 17, 2022
- Manufacturer
- COOK INC
- Product Code
- JOH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL REPORTER OCCUPATION: DIRECTOR OF MED-SURG COMMODITIES. 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 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.
INVESTIGATION ¿ EVALUATION: IT WAS REPORTED BY (B)(6) HOSPITAL (UNITED STATES) THAT TWO BLUE RHINO DILATORS IN BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY(S) (RPN: C-PTISY-100-HC-G-NA-FLEX8.5, LOT: UNKNOWN) BENT. THE DEVICES WERE REQUIRED BY AN UNKNOWN PATIENT FOR A PERCUTANEOUS TRACHEOSTOMY PROCEDURE. DURING THE PROCEDURE, THE BLUE RHINO DILATORS WERE NOTED TO BE TOO PLIABLE AND SUBSEQUENTLY BENT DURING ADVANCEMENT. AS A RESULT, THE USER WAS UNABLE TO DILATE THE TRACHEAL RINGS, SO THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) TO COMPLETE THE PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION INCLUDING THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO PHYSICAL EXAMINATION COULD BE CONDUCTED. 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 REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED DUE TO THE LACK OF LOT INFORMATION PROVIDED BY THE FACILITY. THERE IS NO EVIDENCE TO SUPPORT THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION OR TO SUGGEST ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE ARE NONCONFORMING. COOK ALSO REVIEWED PRODUCT LABELING. THE CURRENT INSTRUCTIONS FOR USE [C_T_PTISGI2_REV0] STATE THE FOLLOWING: "TRACHEOSTOMY PROCEDURE 2. AFTER INTRODUCING LOCAL ANESTHESIA, MAKE A 1.5-2.0 CM SKIN INCISION (VERTICAL OR HORIZONTAL) AT THE CHOSEN INSERTION SITE. 3. IF DESIRED, USE A CURVED MOSQUITO CLAMP TO GENTLY DISSECT VERTICALLY AND TRANSVERSELY DOWN TO THE ANTERIOR TRACHEAL WALL. WITH A FINGERTIP, DISSECT THE FRONT OF THE TRACHEA, IN THE MIDLINE, FREE OF ANY TISSUES AND IDENTIFY THE CRICOID CARTILAGE. DISPLACE THE ISTHMUS OF THE THYROID DOWNWARD, IF PRESENT. NOTE: AN ADEQUATE SKIN INCISION AND BLUNT DISSECTION OF THE SUBCUTANEOUS TISSUE CAN MINIMIZE THE NEED FOR EXCESSIVE FORCE AND TORQUE THROUGHOUT THE PROCEDURE. EXCESSIVE FORCE AND ROTATION MAY LEAD TO LONG-TERM COMPLICATIONS. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE LIKELY CAUSE FOR THE EVENT WAS DUE TO A COMPONENT FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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.
CUSTOMER FEEDBACK WAS INITIALLY REPORTED TO COOK REGARDING THE DILATOR PROVIDED IN THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY. THE CUSTOMER INDICATED THE DILATOR WAS PLIABLE AND BENDS AND THE USER IS UNABLE TO DILATE THE TRACHEAL RINGS. ADDITIONAL INFORMATION WAS REQUESTED AND WAS NOT PROVIDED UNTIL (B)(6) 2022 DURING A VIDEO CALL BETWEEN THE CUSTOMER AND THE COOK SALES REPRESENTATIVE. IT WAS AT THIS TIME THAT THIS FAILURE WAS REPORTED TO HAVE OCCURRED TWICE. EXACT EVENT DATES WERE NOT ABLE TO BE PROVIDED, BUT THE EVENTS OCCURRED OVER THE COURSE OF THREE DAYS. TWO OTHER KITS WERE USED, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211368 | 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 |