MAUDE Adverse Event Report: COOK INCORPORATED Cook; Tube, tracheal (w/wo connector)

Model Number	G57622
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The airway exchange catheter is discolored in the packaging.

• Brand Name: Cook
• Common Device Name: Tube, tracheal (w/wo connector)
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 50896853
• Report Number: 50896853
• Device Sequence Number: 10761905
• Product Code: BTR
• UDI-Device Identifier: 00827002576223
• UDI-Public: (01)00827002576223
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/14/2026
• Report Date (Section F): 08/14/2026

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
• Device Model Number: G57622
• Device Catalogue Number: C-CAE-14.0-83-01
• Device Lot Number: 17094943
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/13/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 08/14/2026