BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
Report
- Report Number
- 1820334-2023-00914
- 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
E3: REGISTERED RESPIRATORY THERAPIST (RRT), MASTER OF HEALTHCARE ADMINISTRATION (MHA). 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 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTION: H5 - ANNEX A 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 THE USED, RETURNED DEVICE FROM LOT 15293394, 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. ONE USED BLUE RHINO WAS RETURNED TO COOK FOR EVALUATION. UPON VISUAL INSPECTION, THE BLUE RHINO WOULD NOT ADVANCE OVER THE SAFETY RIDGE OF THE WHITE CATHETER. THE WHITE CATHETER HAD MULTIPLE KINKS ALONG THE SHAFT AND ANOTHER KINK AT THE SAFETY RIDGE. DUE TO THE SAFETY RIDGE OF THE WHITE CATHETER BEING DAMAGED, THE DEVICE WAS NOT ABLE TO BE CONFIRMED FOR NON-CONFORMANCES. 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 15293394 AND THE RELATED SUBASSEMBLY LOTS REVEALED NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND ONE ADDITIONAL COMPLAINT FROM THE SAME USER FACILITY. ADDITIONAL SUBASSEMBLY LOTS MADE BY THE RELEVANT OPERATORS FROM (B)(6) 2022 WERE REVIEWED AND REVEALED RELATED NON-CONFORMANCES FOR "SAFETY RIDGE TOO SMALL" IN WHICH THE NON-CONFORMING PRODUCT WAS SCRAPPED. NO OTHER COMPLAINTS WERE NOTED FROM THE FINAL LOTS. THERE ARE 100% INSPECTIONS IN PLACE TO IDENTIFY THIS FAILURE. 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) POTNETIAL 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 ADDITIONAL 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. 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 DISCOVERED THAT THE BLUE RHINO DILATOR ADVANCED WITH SLIGHT RESISTANCE OVER THE SAFETY RIDGE OF THE GUIDING CATHETER. THE SAFETY RIDGE OF THE GUIDING CATHETER WAS FLATTENED/SMASHED.
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 |
|---|---|---|---|---|---|---|---|
| 1616538 | BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY | JOH TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | COOK INC | N/A | 15293394 | 00827002577039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |