MAUDE Adverse Event Report: COOK INCORPORATED WAYNE; CATHETER AND TIP, SUCTION

Model Number	G56537
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Introducer was left in the chest tube after the completion of the procedure.Would recommend cook to consider modification of the introducer with a label or fitting to make its presence more notable.

• Brand Name: WAYNE
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 23356236
• Report Number: 23356236
• Device Sequence Number: 8871086
• Product Code: JOL
• UDI-Device Identifier: 00827002565371
• UDI-Public: (01)00827002565371
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/29/2025
• Report Date (Section F): 09/29/2025

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: G56537
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497-IMH
• Device Lot Number: 16678471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/29/2025