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

Catalog Number C-TQTSY-2000

Device Problem Component(s), broken (1103)

Patient Problem Pneumothorax (2012)

Event Date 05/16/2014

Event Type  Injury  

Event Description

A (b)(6) male pt with small cell lung carcinoma underwent a right chest tube insertion into the right pleural space on approximately (b)(6) 2014.Four days after the chest tube insertion, the distal adaptor connecting the chest tube to the evacuation system became dislodged when the pt moved in bed.The chest tube was replaced over guide wire due to the presence of a pneumothorax that we could not evacuate with the original tube.The pt developed a pneumothorax.This caused him increased respiratory failure and hypoxemia.

Manufacturer Narrative

(b)(4).Event evaluation: still under investigation.

• Brand Name: THAL-QUICK CHEST TUBE TRAY
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47402 ; 8123392235
• MDR Report Key: 3894110
• MDR Text Key: 4423147
• Report Number: 1820334-2014-00280
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-TQTSY-2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/16/2014
• Event Location: Hospital
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 47