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

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Codes	Pneumothorax (2012); No Code Available (3191)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Occupation: unknown.Pma/510(k) #: exempt.(b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the connecter of a thal-quick chest tube set was found broken at the junction with the drain.The device was placed in the patient's pleural space to drain a pre-existing pleural effusion on (b)(6) 2020.During the night four days after placement, the drain was found disconnected, leaving it in the open.Consequently, this caused the patient to develop a small iatrogenic pneumothorax, which was confirmed by x-ray imaging.Prior to this, no issues with the device were noted.Following this incident, a new device was placed.Additional information regarding the patient has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: 24mar2020 correction: h6- device code investigation ¿ evaluation it was reported by (b)(6), switzerland that a thal-quick device (rpn:c-tqts-2400, lot number 9398994) was broken at the junction of the connector/drain.The patient was reported to be a male that was diagnosed with a pleural effusion.The device had been placed on (b)(6) 2020 to drain the pleural effusion.During the night on (b)(6).2020 or in the early hours of (b)(6) 2020, it was discovered that the drain had disconnected; the conical end of the drain had separated and was found to be open to air.This caused an iatrogenic pneumothorax that was confirmed by x-ray.The device was removed and a new drain was put in place to treat the iatrogenic pneumothorax and to continue to drain the initial pleural effusion.A review of the complaint history, device history record, drawing, instructions for use (ifu), quality control and specifications, as well as a visual inspection and dimensional verification of the returned device were conducted during the investigation.The complainant returned one proximal fitting for evaluation.The device examination found the device was measured within specification.Glue residue was found in the distal end of the fitting and biomatter was present on the device.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file found that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record revealed no relevant nonconformances or additional complaints associated with this device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: precautions: "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." instructions for use: "9.With the wire guide still positioned within the pleural space, advance the chest tube inserter/chest tube assembly over the wire guide and into the pleural space.Note: if resistance is encountered during chest tube assembly insertion, determine the cause of resistance and take necessary action to relive resistance before proceeding." how supplied: "upon removal from the package, inspect the product to ensure no damage has occurred." although the affected component is supplied to cook by an external supplier, a new supplier investigation was not initiated in response to this incident due to the device being returned and measured within specification.A supplier corrective action request (scar) was previously opened for this issue, and from representative testing, found no evidence of a manufacturing-related cause of failure.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause was established as component failure without a manufacturing or design deficiency.It¿s possible that excessive forces were used during placement, manipulation, or maintenance, contributing to the failure; however, this cannot be confirmed.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.
Event or Problem Description
No additional patient/event information has been received since the previous medwatch report was sent.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9758239
• Report Number: 1820334-2020-00476
• Device Sequence Number: 559551
• Product Code: GBX
• UDI-Device Identifier: 00827002041370
• UDI-Public: (01)00827002041370(17)211220(10)9398994
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2021
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-2400
• Device Lot Number: 9398994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention