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

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The customer reported that the thal-quick chest tube set "clotted off" (sic).No further information was provided by the customer.Additional information is trying to be obtained.It is unknown if the complaint product is available for return; as of the date of this report, no device has yet been received for evaluation.

Manufacturer Narrative

B5: additional information received (27mar2018) identified the chest tube was placed into the lateral l chest for a 30% pneumothorax with small effusion seen on ct chest, later discovered to be seroanguineous fluid.It was also clarified that the clot occurred distal 2cm of the tube, the clot was discovered within 15 minutes, prior to confirmation of placement by cxr (chest x-ray), and the complaint device was hooked up to continuous suction though the suction was later found to be faulty and not provide continuous suction as it would short in and out.The customer also reported that of note, there was significant difficulty in obtaining a superior direction of the tube despite repositioning attempts and a cephalad track.Investigation/evaluation: a review of the documentation, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The device manufacturing record was reviewed and no notable gaps in production or processing controls were noted.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.This device comes packaged with an instructions for use (ifu) document that includes precautions, warnings, etc.The ifu states that states that this product is intended for use by physicians trained and experienced in percutaneous pleural drainage techniques.Standard techniques for placement of chest tubes should be employed.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.The customer did mention that the suction machine that the device was used with was not providing fully continuous suction flow.If the flow of serosanguineous fluid is not continuous, it is feasible to believe that clots will form when the suction cuts off, as reported.However, without more information concerning the suction machine and the event, the root cause is only possibly product use or handling related.The appropriate personnel were notified, and we will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7372421
• MDR Text Key: 103543053
• Report Number: 1820334-2018-00744
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-1400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2018
• Patient Sequence Number: 1