BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
Report
- Report Number
- 1820334-2023-00915
- Event Type
- Malfunction
- Date Received
- July 17, 2023
- Report Date
- October 12, 2023
- Manufacturer
- COOK INC
- Product Code
- JOH
- UDI-DI
- 00827002577039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
REGISTERED RESPIRATORY THERAPIST (RRT), MASTER OF HEALTHCARE ADMINISTRATION (MHA). 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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
INVESTIGATION ¿ EVALUATION: MULTIPLE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAYS (RPN: C-PTISY-100-HC-G-NA) FROM DIFFERENT LOT NUMBERS WERE RETURNED COOK FROM (B)(6) HOSPITAL (UNITED STATES). ON 11JUL2023, DURING INSPECTION OF A DEVICE RETURNED PRIOR TO USE FROM LOT 15221134, COOK FOUND THAT THE BLUE RHINO DILATOR ADVANCED OVER THE SAFETY RIDGE OF THE WHITE GUIDING CATHETER. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST, AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. SEVEN DEVICES FROM LOT 15221134 WERE RETURNED TO COOK FOR EVALUATION. UPON INSPECTION, ONE PRIOR TO USE BLUE RHINO ADVANCED OVER THE WHITE CATHETER'S SAFETY RIDGE. THE WHITE CATHETER HAD 3 KINKS ALONG THE SHAFT, AND ONE OF THE KINKS WAS AT THE SAFETY RIDGE. THE BLUE RHINO AND WHITE CATHETER OF THE OTHER SIX RETURNED DEVICES WERE WITHIN SPECIFICATION. COOK DID NOT CONFIRM THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION, DUE TO THE DAMAGES TO THE WHITE CATHETER¿S SAFETY RIDGE. ADDITIONALLY, 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 DHRS FOR THE REPORTED COMPLAINT DEVICE LOT 15221134 AND THE RELATED SUBASSEMBLY LOTS REVEALED NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. INSTRUCTIONS FOR USE (IFU) C_T_PTISG2_REV0 SUPPLIED WITH THE COMPLAINT RPN WERE REVIEWED FOR INFORMATION RELATED TO REPORTED FAILURE MODE. THE IFU STATES: ¿CONTRAINDICATIONS¿ PATIENTS WITH ENLARGED THYROIDS, NONPALPABLE CRICOID CARTILAGE, PREVIOUS SURGERY AT THE TRACHEOSTOMY SITE (E.G. THYROIDECTOMY). POTENTIAL ADVERSE EVENTS: PERFORATION OF THE TRACHEA, FAILED TRACHEOSTOMY TUBE PLACEMENT, HYPOXIA. TRACHEOSTOMY PROCEDURE: 1. PALPATE THE LANDMARK STRUCTURES (THYROID NOTCH, CRICOID CARTILAGE) TO ASCERTAIN PROPER LOCATION FOR TRACHEOSTOMY TUBE PLACEMENT. ACCESS AND ULTIMATELY TUBE PLACEMENT IS IDEALLY MADE AT THE LEVEL BETWEEN THE FIRST AND SECOND TRACHEAL CARTILAGES OR BETWEEN THE SECOND D THIRD TRACHEAL CARTILAGES WHENEVER FEASIBLE. 2. ¿ MAKE A 1.5-2.0 CM SKIN INCISION (VERTICAL OR HORIZONTAL) AT THE CHOSEN INSERTION SITE ¿ NOTE: AN ADEQUATE SKIN INCISION AND BLUNT DISSECTION OF THE SUBCUTANEOUS TISSUE CAN MINIMIZE THE NEED FOR EXCESSIVE FORCE¿ 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. NOTE: ALIGN THE PROXIMAL END OF THE GUIDING CATHETER AT THE MARK ON THE PROXIMAL PORTION OF THE WIRE GUIDE. THIS WILL ENSURE THAT THE DISTAL END OF THE GUIDING CATHETER IS PROPERLY POSITIONED BACK ON THE WIRE GUIDE, PREVENTING POSSIBLE TRAUMA TO THE POSTERIOR TRACHEAL WALL DURING SUBSEQUENT MANIPULATIONS. NOTE: BRONCHOSCOPIC GUIDANCE MAY ALSO PREVENT POSSIBLE TRAUMA TO THE POSTERIOR TRACHEAL WALL. 15. BEGIN TO DILATE THE TRACHEAL ACCESS SITE BY ADVANCING THE GUIDING CATHETER AND BLUE RHINO G2-MULTI DILATOR INTO THE TRACHEA. TO PROPERLY ALIGN THE DILATOR ON THE WIRE GUIDE/GUIDING CATHETER ASSEMBLY, POSITION THE PROXIMAL END OF THE DILATOR AT THE SINGLE POSITIONING MARK ON THE GUIDING CATHETER. THIS WILL ENSURE THAT THE DISTAL TIP OF THE DILATOR IS PROPERLY POSITIONED AT THE SAFETY RIDGE ON THE GUIDING CATHETER TO PREVENT POSSIBLE TRAUMA TO THE POSTERIOR TRACHEAL WALL DURING INTRODUCTION. 16. ADVANCE AND PULL BACK THE DILATING ASSEMBLY SEVERAL TIMES TO EFFECTIVELY DILATE THE TRACHEAL ACCESS SITE. NOTE: THE WIRE GUIDE MUST ALWAYS LEAD THE DILATORY AND THE GUIDING CATHETER ASSEMBLY TO PREVENT POSSIBLE TRAUMA TO THE POSTERIOR TRACHEAL WALL DURING DILATION. CARE SHOULD BE TAKEN TO KEEP THE GUIDING CATHETER ASSEMBLY PROPERLY ALIGNED WITH THE MARK ON THE PROXIMAL PORTION OF THE WIRE GUIDE. THIS WILL ENSURE THAT THE TIP OF THE GUIDING CATHETER ASSEMBLY DOES NOT ADVANCE BEYOND THE DISTAL TIP OF THE WIRE GUIDE WITHIN THE TRACHEA¿¿ THE INFORMATION PROVIDED UPON REVIEW OF DEVICE MASTER RECORD, PRODUCT LABELING, DEVICE HISTORY RECORD, AND DEVICE FAILURE ANALYSIS, 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, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE EVENT. THERE IS DAMAGE AT THE WHITE CATHETER¿S SAFETY RIDGE THAT ALLOWS THE BLUE RHINO TO ADVANCE OVER. IT IS UNKNOWN HOW THE CATHETER BECAME KINKED IN MULTIPLE LOCATIONS. THE MATERIAL OF THE GUIDING CATHETER IS SOFT AND CAN BE COMPRESSED WITH FORCE. 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.
THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION IN AN OPENED CONDITION. DURING THE DEVICE INVESTIGATION, IT WAS DETERMINED THAT PARTS WERE NOT RETURNED IN THE TRAY (GAUZE AND DRAPE). ADDITIONALLY, THE BLUE RHINO DILATOR ADVANCED OVER THE SAFETY RIDGE OF THE GUIDING CATHETER. THE GUIDING CATHETER ALSO HAD SEVERAL AREAS THAT WERE BENT.
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 |
|---|---|---|---|---|---|---|---|
| 1703945 | BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY | JOH TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | COOK INC | N/A | 15221134 | 00827002577039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |