MAUDE Adverse Event Report: COOK INCORPORATED BLUE RHINO; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	G57703
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was using a blue rhino dilator to place a new tracheostomy.The physician stated that the white flexible tubing that goes through the dilator did not stop at the normal stopping point which caused the wire to be pushed out.This put the patient at risk for losing a airway.Patient's saturations dropped to 70%.

• Brand Name: BLUE RHINO
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 23423552
• Report Number: 23423552
• Device Sequence Number: 12822491
• Product Code: JOH
• UDI-Device Identifier: 00827002577039
• UDI-Public: (01)00827002577039
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2025
• Report Date (Section F): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G57703
• Device Catalogue Number: C-PTISY-100-HC-G-NA
• Device Lot Number: 16579740
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 159 KG
• Date Report Sent to FDA: 09/11/2025