WAYNE PNEUMOTHORAX TRAY

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D9, D10, E4. CORRECTION: B1, B2, H1, H3, H6 - ANNEX F. H3: NO DEVICE RETURN 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 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

IN ADDITIONAL INFORMATION REPORTED (B)(6) 2026, ALL CATHETERS WERE SECURED IN PLACE WITH SUTURE AND MEDICAL ADHESIVE. THE DURATION THAT THE CATHETERS REMAINED IN PLACE VARIED, BUT THESE INCIDENTS TYPICALLY OCCURRED WITHIN THE FIRST 24 TO 48 HOURS. DURING THIS TIME, THE PATIENTS WERE BEDRIDDEN, AND THE TUBES WERE NOT PULLED OUT DUE TO PATIENT ACTIVITY; DOCUMENTATION IS MAINTAINED TO TRACK INCIDENTS SUCH AS TUBES BEING STEPPED ON. THERE WAS ONE REPORTED EPISODE OF A TENSION PNEUMOTHORAX WITH AN UNKNOWN PATIENT, BUT ULTIMATELY THE PATIENT DID OK. IN ALL CASES, THE CATHETERS REQUIRED REPLACEMENT BY INTERVENTIONAL RADIOLOGY AND HOSPITAL STAYS WERE PROLONGED. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED.

Description of Event or Problem

IT WAS REPORTED THAT THERE HAVE BEEN FIVE INSTANCES OF UNKNOWN WAYNE PNEUMOTHORAX CATHETER MIGRATION AND KINKING OVER THE PAST SEVERAL MONTHS. THIS REPORT CAPTURES ONE INSTANCE OF CATHETER MIGRATION THAT OCCURRED ON (B)(6) 2025. THREE OTHER SIMILAR INSTANCES OF CATHETER MIGRATION ARE REFERENCED IN REPORTS WITH PATIENT IDENTIFIERS: (B)(6). ANOTHER INSTANCE OF CATHETER KINKING AND MIGRATION IS REFERENCED IN REPORT WITH PATIENT IDENTIFIER: (B)(6). 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.

Additional Manufacturer Narrative

H3 - DEVICE EVALUATED BY MFG?: DEVICE RETURN STATUS IS CURRENTLY UNKNOWN. 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

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

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT THERE HAVE BEEN FIVE INSTANCES OF MIGRATION AND/OR KINKING WITH DRAINAGE CATHETERS FROM WAYNE PNEUMOTHORAX TRAYS. THESE CATHETERS WERE PLACED BY MULTIPLE DIFFERENT EMERGENCY DEPARTMENT PROVIDERS. INPATIENT PROVIDERS REPORTED THE PNEUMOTHORAX TUBES APPEAR TO HAVE MIGRATED OUT OF THE TARGET LOCATION DESPITE BEING SECURED WITH SUTURE; ALL CATHETERS WERE SECURED IN PLACE WITH SUTURE AND MEDICAL ADHESIVE. THE DURATION THAT THE CATHETERS REMAINED IN PLACE VARIED, BUT THESE INCIDENTS TYPICALLY OCCURRED WITHIN THE FIRST 24 TO 48 HOURS. DURING THIS TIME, THE PATIENTS WERE BEDRIDDEN, AND THE TUBES WERE NOT PULLED OUT DUE TO PATIENT ACTIVITY; DOCUMENTATION IS MAINTAINED TO TRACK INCIDENTS SUCH AS TUBES BEING STEPPED ON. THERE WAS ONE REPORTED EPISODE OF A TENSION PNEUMOTHORAX WITH AN UNKNOWN PATIENT, BUT ULTIMATELY THE PATIENT DID OK. IN ALL CASES, THE CATHETERS REQUIRED REPLACEMENT BY INTERVENTIONAL RADIOLOGY AND HOSPITAL STAYS WERE PROLONGED. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED. THIS REPORT CAPTURES ONE INSTANCE OF CATHETER MIGRATION THAT OCCURRED ON (B)(6) 2025. THREE OTHER SIMILAR INSTANCES OF CATHETER MIGRATION ARE REFERENCED IN REPORTS WITH PATIENT IDENTIFIERS: (B)(6). ANOTHER INSTANCE OF CATHETER KINKING AND MIGRATION IS REFERENCED IN REPORT WITH PATIENT IDENTIFIER: (B)(6). REVIEWS OF DOCUMENTATION INCLUDING THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES FOR THE DEVICE 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 FOR THIS 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 THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [C_T_WAYNEMOD_REV5] ¿WAYNE PNEUMOTHORAX SET FOR SELDINGER PLACEMENT,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿11. SECURE CATHETER IN POSITION AT THE ENTRY SITE BY USING BIO-OCCLUSIVE DRESSING OR SUTURING IF DESIRED. 12. THE CATHETER AND CONNECTED DRAIN LINES SHOULD BE SECURED TO THE PATIENT. EXCESSIVE TENSION ON CATHETER CONNECTIONS MAY CAUSE CATHETER/HUB SEPARATION OR ACCIDENTAL CATHETER DISLODGEMENT.¿. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK WAS UNABLE TO ESTABLISH A CAUSE FOR THIS FAILURE. IT IS POSSIBLE THAT THE PATIENT'S CONDITION CONTRIBUTED TO THE CATHETER MOVING AROUND IN THE INSERTION SITE, BUT COOK CANNOT CONFIRM THIS. 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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4 - MODEL # AND CATALOG #, G4. G4 - PMA/510(K) #: EXEMPT. 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.

Description of Event or Problem

IN ADDITIONAL INFORMATION RECEIVED 20JAN2026, IT WAS REPORTED THAT THE INPATIENT PROVIDERS ARE REPORTING THE PNEUMOTHORAX TUBES APPEAR TO BE MIGRATING OUT OF THE TARGET LOCATION DESPITE BEING SECURED WITH SUTURES. THESE TUBES HAVE BEEN PLACED BY MULTIPLE DIFFERENT EMERGENCY DEPARTMENT PROVIDERS. IMAGING PROVIDED BY THE CUSTOMER REVEALS HOW THE CATHETERS HAVE MIGRATED OR MOVED FROM INITIAL PLACEMENT.

Description of Event or Problem

ALL INSTANCES OF CATHETER MIGRATION AND KINKING OCCURRED IN THE EMERGENCY DEPARTMENT.

Additional Manufacturer Narrative

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.