WAYNE PNEUMOTHORAX TRAY

Additional Manufacturer Narrative

E1- TITLE: BSN, RN, CNOR G4 - PMA/510(K) #: EXEMPT. H3 - DEVICE EVALUATED BY MFG?: DEVICE NOT RETURNED TO MANUFACTURER. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE WAYNE PNEUMOTHORAX CHEST TUBE ONE-WAY VALVE WAS MISPLACED DURING A BEDSIDE PROCEDURE IN THE INTENSIVE CARE UNIT (ICU). DURING THE OVERNIGHT HOURS, THE CHEST TUBE FAILED TO DRAIN AS EXPECTED, PROMPTING MULTIPLE INSPECTIONS BY PROVIDERS AND NURSING STAFF DUE TO THE PATIENT¿S DETERIORATING CONDITION. ON THE MORNING OF THURSDAY, THE PHYSICIAN EVALUATED THE DEVICE AND REMOVED THE CONNECTOR PIECE. THE TUBE THEN BEGAN TO DRAIN A SIGNIFICANT AMOUNT OF FLUID. IT WAS LATER DISCOVERED THAT THE CONNECTOR WAS A ONE-WAY VALVE, WHICH WAS INCORRECTLY PLACED, PREVENTING THE PNEUMOTHORAX FROM DRAINING POST-PLACEMENT. THE VALVE BODY IS MADE OF CLEAR PLASTIC AND HAS ONLY TEXT WITH THE WORD ¿FLOW¿ AND AN ARROW TO INDICATE DIRECTION. THESE MARKINGS WERE REPORTED TO BE DIFFICULT TO SEE AND LACK ANY COLOR OR TEXTURE CONTRAST, MAKING PROPER ORIENTATION CHALLENGING DURING CLINICAL USE. THE PATIENT EXPERIENCED COMPLICATIONS DUE TO THE POOR DESIGN AND REQUIRED AN ADDITIONAL, UNSPECIFIED PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT. NO OTHER HARM WAS REPORTED TO THE PATIENT.

Additional Manufacturer Narrative

INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT THE CHEST DRAIN VALVE (CDV) FROM A WAYNE PNEUMOTHORAX TRAY WAS MISPLACED DURING A BEDSIDE PROCEDURE IN THE INTENSIVE CARE UNIT (ICU). ON WEDNESDAY (B)(6) 2025, AN X-RAY SHOWED THAT AN UNKNOWN PATIENT HAD A RIGHT PNEUMOTHORAX AND REQUIRED TREATMENT WITH THE WAYNE DEVICE. AFTER THE DEVICE WAS PLACED, IT WAS DISCOVERED THAT THE CATHETER DID NOT DRAIN OVERNIGHT. THE LINE WAS INSPECTED BY MULTIPLE PROVIDERS AND NURSING STAFF DUE TO THE PATIENT¿S CONDITION. ON THURSDAY MORNING, ANOTHER PHYSICIAN EVALUATED THE DEVICE AND REMOVED THE CDV. THE TUBE THEN BEGAN TO DRAIN A SIGNIFICANT AMOUNT OF FLUID. IT WAS LATER DISCOVERED THAT THE ONE-WAY CDV WAS PLACED INCORRECTLY WHICH PREVENTED THE PNEUMOTHORAX FROM DRAINING. IT WAS NOTED THAT THE DIRECTION ARROW ON THE VALVE WAS HARD TO SEE. AS A RESULT, THE PATIENT EXPERIENCED COMPLICATIONS AND REQUIRED AN ADDITIONAL, UNSPECIFIED PROCEDURE. NO OTHER ADVERSE EVENTS WERE REPORTED. REVIEWS OF THE DRAWING, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. 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) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. AN EXPANDED SALES SEARCH TO THE CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD COOK ALSO REVIEWED PRODUCT LABELING. THE IFU [C_T_WAYNEMOD_REV5] SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: ¿9. REMOVE THE WIRE GUIDE AND CATHETER OBTURATOR. ATTACH CATHETER TO CONNECTING TUBE WITH STOPCOCK AND COOK CHEST DRAIN VALVE. ATTACH COOK CHEST DRAIN VALVE IN DIRECTION INDICATED BY ARROW ON VALVE. NOTE: CHEST DRAIN VALVE MAY BE OBVIATED IF CATHETER IS TO BE CONNECTED TO A WATER SEAL SUCTION APPARATUS OR SIMILAR MECHANICAL SUCTION DEVICE. DO NOT CONNECT CATHETER DIRECTLY TO WALL SUCTION.¿ BASED ON THE AVAILABLE INFORMATION, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDES UNINTENDED USE ERROR AS THE CAUSE FOR THIS EVENT. THE INSTRUCTIONS FOR USE STATES TO PLACE THE CHEST DRAIN VALVE IN THE DIRECTIONS INDICATED BY THE ARROW. THERE IS ALSO A LABEL APPLIED TO THE CHEST VALVE PROVIDING INFORMATION FOR THE CORRECT ORIENTATION OF THE DEVICE. 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 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.

Description of Event or Problem

NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.