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

Model Number N/A

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Initial reporter occupation: unknown.Pma/510(k) #: exempt.(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

It was reported that kinking occurring in the thal-quick chest tube set catheter has caused immediate complications.The physician reported witnessing these complications "repeatedly.".

Event Description

No additional information regarding the patient or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.H6 - results code: tube kinks.Investigation ¿ evaluation.A review of the complaint history, drawing, instructions for use (ifu), quality control, and specifications of the device were conducted during the investigation.The visual inspection of the complaint device could not be completed as the complaint device was not returned.A document based investigation evaluation was performed.A review of the device master record concluded that proper procedures are in place to identify and prevent this failure mode prior to device distribution.The device history record could not be reviewed due to a lack of information provided by the complaint facility; a database search could not adequately narrow down a list of potential lots shipped to the customer.There is no evidence to suggest there is any nonconforming product in house or in field.Additionally, a review of the product labeling for the device was completed.The instructions for use, c_t_thal_rev10, states the following instructions related to the reported failure mode: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no inspection of returned product, and the results of the investigation, a definitive cause could not be established.No information on the patient or maintenance of the device is available.It is possible that the device became kinked during placement or due to maintenance of the device.It is also possible that excessive forces caused by the patient could have led to kinking of the device.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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, that a death or serious injury occurred, nor that any cook device caused, 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: 8776595
• MDR Text Key: 150579185
• Report Number: 1820334-2019-01657
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-1200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention