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

Catalog Number C-TQTS-800

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2020

Event Type  Injury  

Manufacturer Narrative

The device was originally reported to be rpn: c-tqts-1400; however, the device was also reported to be a "drain thoracique" with no reference or lot information currently available.Therefore, device information currently remains unknown.(b)(6).(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 a "microcut" was noticed at the base of an unknown cook catheter, referred to as a "drain thoracique".This resulted in leakage "of the drain".Consequently, the device had to be replaced with a new catheter.Additional information regarding the patient and device has been requested but is currently unavailable.

Event Description

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

Manufacturer Narrative

G5 ¿ pma/510(k): exempt.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.It was reported that the catheter from a thal-quick chest tube set (c-tqts-800) from an unknown lot leaked from a micro-cut at the hub.The complaint device was replaced with a new catheter.Cook became aware of this event on 30dec2021 upon being notified by gh nord essone.The patient reportedly experienced no adverse effects as a result of this incident.A review of documentation including the complaint history, device history record, instructions for use (ifu) and quality control of the device, as well as a visual inspection and functional test of the returned device was conducted during the investigation.One used device with biological matter present throughout was received for evaluation.A small hole was found just below the hub.A leak test was performed and confirmed leakage at the hole.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient controls are in place to detect the failure mode prior to release.A review of the design history file (dhf) found that the risks of this device are acceptable when weighed against the benefits.A review of the exact device history record (dhr) could not be completed due to the lack of lot information from the facility.A review of sales records to the user facility over three years prior to the date of event showed five potential lot numbers (10183655, 10266131, 10284493, 13215963 and 13585596).These and all related subassembly lots showed no related nonconformances.It should be noted that no other complaints were associated with these five lot numbers.Since there are no related nonconformances or other complaints from these potential lots, there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information related to the reported failure mode.How supplied.Upon removal from package, inspect the product to ensure no damage has occurred.It was found that the affected component is supplied from cook polymer technology and a supplier investigation was requested for this occurrence.The supplier reviewed lot records from the five potential lots determined and found consistent tensile data and no anomalies.It was concluded that the device was manufactured within specification.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the event.It is possible that user manipulation of the device and/or patient movement contributed to the damage, but neither possibility can be confirmed with certainty.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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.

Event Description

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

• 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: 11123250
• MDR Text Key: 225356261
• Report Number: 1820334-2021-00022
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-TQTS-800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention