MAUDE Adverse Event Report: Cook Inc THAL-QUICK CHEST TUBE SET; GBX Catheter, Irrigation

Model Number	G06787
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thal-quick chest tube twisted and kinked.The chest tube was placed on (b)(6) 2026 in a 25-year-old male patient presenting to the emergency department with a spontaneous pneumothorax.The device was connected to a drainage system.Five days later, on (b)(6) 2026, despite functional drainage system suction, no bubbling in the drainage system was observed.The dressing was removed to check the drainage tube's path and assess for any kink.It was discovered that the tube was twisted on itself several times, which appeared to be preventing the suction from working correctly.Initially, the drain was untwisted, and an additional dressing was applied to the thigh to prevent recurrence.The following day, on (b)(6) 2026, as the absence of bubbling persisted, an attempt was made to clear the obstruction by injecting 10 ml of 0.9% nacl.This maneuver temporarily improved the situation, resulting in the appearance of bubbles.However, given the lack of improvement on the x-ray, it was decided on (b)(6) 2026, to replace the chest tube with one of a different gauge.This incident resulted in a delay in the management and progression of the spontaneous pneumothorax, consequently prolonging the patient's hospital stay.This customer has also reported other multiple occurrences of chest tube drains kinking or twisting upon themselves.These other occurrences will be captured in an additional report with patient identifier (b)(6).
Event or Problem Description
Additional information was received 29sep2026.The patient's follow up chest x-ray on (b)(6)2026 revealed lung re-expansion, with a slight persistent apical separation.
Additional Manufacturer Narrative
E3 - occupation: hospital pharmacy resident, g4 ¿ pma/510(k) #: exempt, h3 - device evaluation anticipated but not yet 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.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 cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Common Device Name: GBX Catheter, Irrigation
• Manufacturer (Section D): Cook Inc; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; +1(812)339-2235
• MDR Report Key: 50935795
• Report Number: 1820334-2026-01012
• Device Sequence Number: 13449246
• Product Code: GBX
• UDI-Device Identifier: 00827002067875
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G06787
• Device Catalogue Number: C-TQTS-1000
• Device Lot Number: 17226852
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Pleu-evac Chest Drainage Systerm.
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 25 YR
• Patient Sex: Male