MAUDE Adverse Event Report: COOK, INC. THAL-QUICK CHEST TUBE SET; CATHETER, IRRIGATION

Model Number G06786

Device Problem Backflow (1064)

Patient Problems Death (1802); Injury (2348); Vascular System (Circulation), Impaired (2572)

Event Date 06/25/2019

Event Type  malfunction  

Event Description

During a right chest tube insertion blood backed up into the chest tube and the patient coded.Upon opening the chest vascular injury was noted.Patient did not survive.There was no autopsy to my knowledge.There was no difficulty inserting the device: it was done correctly and under observation and in a planned/controlled situation.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8850212
• MDR Text Key: 152917416
• Report Number: 8850212
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2019

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 Operator: Health Professional
• Device Model Number: G06786
• Device Catalogue Number: C-TQTS-800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 DA