MAUDE Adverse Event Report: COOK INC DRAINAGE BAG CONNECTOR CONNECTING TUBE; GCD; CONNECTOR, CATHETER

Model Number	G02278
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 - pma/510(k) #: exempt h3 - device evaluated by mfg.? device evaluation anticipated but has not begun.Awaiting device return.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.
Event or Problem Description
Upon opening the packaging of a drainage bag connector connecting tube, an unknown dark substance was found near the hub of the stopcock.The device was not used and did not make patient contact.A photo provided by the customer confirms a dark substance near the stopcock.No adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event has been requested but is currently unavailable.
Event or Problem Description
In additional information received on 27jan2026, it was reported that the functionality of the device was not tested prior to noticing the damage, as the dark spot was considered to be a potential contaminate.As a result, the device was not prepped/used.It was confirmed that the device was stored according to the conditions noted on the label.It is not believed that any handling conditions of the facility could have contributed to the issue.
Additional Manufacturer Narrative
Additional information: b5 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 device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: DRAINAGE BAG CONNECTOR CONNECTING TUBE
• Common Device Name: GCD; CONNECTOR, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 23840469
• Report Number: 1820334-2025-01575
• Device Sequence Number: 9526711
• Product Code: GCD
• UDI-Device Identifier: 00827002022782
• UDI-Public: (01)00827002022782(17)281006(10)16812914
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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
• Operator of Device: Health Professional
• Device Model Number: G02278
• Device Catalogue Number: CTU14.0-30-ST
• Device Lot Number: 16812914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown