BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
Report
- Report Number
- 1820334-2022-00061
- Event Type
- Malfunction
- Date Received
- January 14, 2022
- Date of Event
- December 29, 2021
- Report Date
- October 20, 2022
- Manufacturer
- COOK INC
- Product Code
- JOH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. CORRECTION: H6 (ANNEX G) INVESTIGATION ¿ EVALUATION (B)(6) CENTER (UNITED STATES) INFORMED COOK 29DEC2021 REGARDING THE DILATORS IN BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SETS AND TRAYS (RPN: C-PTISY-100-HC-G-NA; LOTS UNKNOWN). DURING A PROCEDURE, IT WAS NOTED THAT THE BLUE RHINO G2-MULTI DILATOR AND TRACHEOSTOMY TUBE LOADING DILATORS ADVANCED OVER THE 8F GUIDING CATHETER MAKING THE PROCEDURE DIFFICULT. SUBSEQUENTLY THE TIP OF THE DILATORS BECAME MISSHAPEN WHEN ENTERING THE TRACHEA WITH THE CATHETER. NO ADVERSE EFFECTS WERE REPORTED FOR THIS EVENT, AND NO OTHER INFORMATION WAS MADE AVAILABLE. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE CUSTOMER DID NOT RETURN THE COMPLAINT DEVICE FOR EVALUATION. COOK WAS UNABLE TO IDENTIFY A LIKE DEVICE TO COMPARE WITH THIS COMPLAINT. COOK WAS UNABLE TO COMPLETE A DEVICE FAILURE ANALYSIS. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) FOR THE BLUE RHINO, ALL LOADING DILATOR SIZES, AND GUIDING CATHETER AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED THE DEVICE HISTORY RECORD (DHR). THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICES. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND IDENTIFIED 3 LOTS SOLD TO THE CUSTOMER IN THE LAST 3 YEARS. A DATABASE SEARCH ON THE 3 CATHETER COMPONENT LOTS (IC14167243, IC13986228, IC14034839) FOUND ONE NONCONFORMANCE THAT COULD MATCH THE FAILURE. THE NONCONFORMING PRODUCT FROM THE COMPONENT LOT (IC14034839) WAS FOR THE OUTER DIAMETER BEING HIGHER THAN SPECIFICATION AND THE PRODUCT WAS SCRAPPED. A DATABASE SEARCH FOR COMPLAINTS ON THE 3 LOTS FOUND NO COMPLAINTS REPORTED FROM THE FIELD. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD AND NO INDICATION THAT THE DEVICES WERE MANUFACTURED OUT OF SPECIFICATION. COOK REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [C_T_PTISGI2_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. THE PRESENCE OF ANOMALOUS BLOOD VESSELS MAY CAUSE EXCESSIVE BLEEDING DURING THE PROCEDURE.¿ PERCAUTIONS: ¿BRONCHOSCOPIC GUIDANCE IS STRONGLY RECOMMENDED DURING PLACEMENT OF THIS DEVICE TO REDUCE THE LIKELIHOOD OF PARATRACHEAL INSERTION AND TO DETERMINE THE INTRATRACHEAL POSITION OF THE NEEDLE, WIRE GUIDE, DILATORS, AND TRACHEOSTOMY TUBE. AN ULTRASOUND EVALUATION OF THE PATIENT¿S NECK PRIOR TO THE PROCEDURE MAY AID IN IDENTIFICATION OF ANATOMICAL VARIANCES.¿ INSTRUCTIONS FOR USE: TRACHEOSTOMY PROCEDURE ¿14. ADVANCE THE BLUE RHINO G2- MULTI DILATOR AND THE GUIDING CATHETER AS A UNIT OVER THE WIRE GUIDE, WHILE MAINTAINING WIRE GUIDE PORTION. 15. BEGIN TO DILATE THE TRACHEAL ACCESS SITE BY ADVANCING THE GUIDING CATHETER AND BLUE RHINO G2-MULTI DILATOR INTO THE TRACHEA. WHILE MAINTAINING THE VISUAL REFERENCE POINTS AND POSITIONING RELATIONSHIPS OF THE WIRE GUIDE, GUIDING CATHETER AND DILATOR, ADVANCE THEM AS A UNIT TO THE SKIN LEVEL MARK ON THE BLUE RHINO G2-MULTI DILATOR.¿ 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 IS RELATED TO COMPONENT FAILURE, WITHOUT EVIDENCE OF MANUFACTURING DEFICIENCIES. 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.
IT WAS REPORTED THAT THE DILATORS OF THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY PASSED OVER THE SAFETY RIDGE OF THE GUIDING CATHETER. DURING A PROCEDURE, IT WAS NOTED THAT THE BLUE RHINO G2-MULTI DILATOR AND TRACHEOSTOMY TUBE LOADING DILATORS ALL PASSED OVER THE "LIP" OF THE WHITE GUIDING CATHETER. THIS MADE THE PROCEDURE DIFFICULT, AS THE SLIDING MADE THE TIP OF THE DILATOR MISSHAPEN WHEN ENTERING THE TRACHEA. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS 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 |
|---|---|---|---|---|---|---|---|
| 806645 | 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 |