BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
Report
- Report Number
- 1820334-2024-00847
- Event Type
- Malfunction
- Date Received
- June 21, 2024
- Report Date
- October 17, 2024
- Manufacturer
- COOK INC
- Product Code
- JOH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED ADDITIONAL INFORMATION: D - PRODUCT IDENTIFIER, D1, D4 (MODEL#, RPN) 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.
INVESTIGATION ¿ EVALUATION. IT WAS REPORTED BY AN INTENSIVE CARE UNIT (ICU) DOCTOR THAT THE BLUE RHINO DILATOR FROM AN UNKNOWN PERCUTANEOUS TRACHEOSTOMY SET WAS DIFFICULT TO ADVANCE IN TO THE PATIENT. IT WAS ALSO REPORTED THAT THE 14 FRENCH PUNCH DILATOR EXPERIENCED DIFFICULTIES. THIS FAILURE OCCURRED WITH FOUR TRACHEOSTOMY PROCEDURES DURING THE COURSE OF A WEEK. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. THIS REPORT WILL FOCUS ON THE DIFFICULT ADVANCEMENT OF THE FOUR BLUE RHINO DILATORS. REVIEWS OF THE DOCUMENTATION INCLUDING QUALITY CONTROL PROCEDURES AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE, 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 IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICES. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. 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: WARNINGS ¿ANATOMIC ANOMALIES MAY MAKE THE PROCEDURE DIFFICULT TO PERFORM.¿ PRECAUTIONS ¿AN ULTRASOUND EVALUATION OF THE PATIENT¿S NECK PRIOR TO THE PROCEDURE MAY AID IN IDENTIFICATION OF ANATOMICAL VARIANCES.¿ INSTRUCTIONS FOR USE TRACHEOSTOMY PROCEDURE ¿ 1. PALPATE LANDMARK STRUCTURES (THYROID NOTCH, CRICOID CARTILAGE) TO ASCERTAIN PROPER LOCATION FOR TRACHEOSTOMY TUBE PLACEMENT. ACCESS AND, ULTIMATELY, TUBE PLACEMENT IS IDEALLY MADE AT THE LEVER BETWEEN THE FIRST AND SECOND TRACHEAL CARTILAGES OR BETWEEN THE SECOND AND THIRD TRACHEAL CARTILAGES WHENEVER FEASIBLE. 2.AFTER INTRODUCING LOCAL ANESTHESIA, MAKE A 1.5-2.0 CM SKIN INCISION (VERTICAL OR HORIZONTAL) AT THE CHOSEN INSERTION SITE. 3. WITH A FINGER TIP, 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. 13. ACTIVATE THE HYDROPHILIC COATING BY IMMERSING THE DISTAL END OF THE BLUE RHINO G2-MULTI DILATOR IN STERILE WATER OR SALINE. 14. ADVANCE THE BLUE RHINO G2-MULTI DILATOR AND THE GUIDING CATHETER AS A UNIT OVER THE WIRE GUIDE, WHILE MAINTAINING WIRE GUIDE POSITION.¿ EVIDENCE GATHERED UPON REVIEW OF DMR, AND PRODUCT LABELING, DOES NOT INDICATE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURN, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED. 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.
B3 - DATE OF EVENT: THE WEEK OF 09JUN2024 THROUGH 13JUN2024. D2A AND D2B: THE IDENTITY OF THE COMPLAINT DEVICE IS UNKNOWN. THEREFORE, THE PRODUCT CODE IS SELECTED BASED ON SUSPECTED DEVICE. E3 - OCCUPATION: RADIOLOGY. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IT WAS REPORTED BY AN INTENSIVE CARE UNIT (ICU) DOCTOR THAT THE BLUE RHINO DILATOR FROM AN UNKNOWN PERCUTANEOUS TRACHEOSTOMY SET WAS DIFFICULT TO ADVANCE IN TO THE PATIENT. IT WAS ALSO REPORTED THAT THE 14 FRENCH PUNCH DILATOR EXPERIENCED DIFFICULTIES. THIS FAILURE OCCURRED WITH FOUR TRACHEOSTOMY PROCEDURES DURING THE COURSE OF A WEEK. 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. THIS REPORT WILL FOCUS ON THE DIFFICULT ADVANCEMENT OF THE FOUR BLUE RHINO DILATORS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 208477 | BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET | JOH TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | COOK INC | G57685 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |