MAUDE Adverse Event Report: COOK INCORPORATED COOK; NEEDLE, CATHETER

Model Number	G09492
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During chest tube placement, a soft distal tip of needle's plastic outer catheter (4mm fragment) was sheared off and remained within the patient's pleural space.

• Brand Name: COOK
• Common Device Name: NEEDLE, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 21025871
• Report Number: 21025871
• Device Sequence Number: 12853850
• Product Code: GCB
• UDI-Device Identifier: 00827002094925
• UDI-Public: (01)00827002094925(17)270717(10)16160855
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/27/2024
• Report Date (Section F): 11/27/2024

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: G09492
• Device Catalogue Number: DTVN-5.0-19-15.0-YUEH
• Device Lot Number: 16160855
• 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: 12/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2024
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Date Report Sent to FDA: 11/27/2024