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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pneumothorax (2012)

Event Date 01/03/2022

Event Type  Injury  

Event Description

After the placement of the cook thal-quick chest tube, it was found to be disconnected from the patient while in the ward.The device was removed and replaced with another brand of chest tube.A photo of the separation was provided by the customer showing the universal (funnel end) of the catheter had separated from the catheter shaft.

Manufacturer Narrative

(b)(6).Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

Additional information provided on 01mar2022.The device was placed for drainage after surgery.The device was connected to a drainage bottle at the time of failure.The damage was discovered "after the day that patient was moved to ward." the device failure caused a pneumothorax.The doctor replaced the device with another chest tube "right away.".

Manufacturer Narrative

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

Investigation ¿ evaluation cook was informed by (b)(6) hospital (taiwan) on 12jan2022 that the catheter in a thal-quick chest tube set (rpn: c-tqts-2400, lot#: 14013265) separated.The device was placed in the patient¿s right chest for post-surgical drainage and was connected to a drainage bottle.The day after the patient was transferred to the ward, separation of the universal hub (funnel end) of the catheter from the catheter shaft was discovered.As a result, the patient suffered a pneumothorax and required an additional procedure to replace the catheter with a competitor¿s product.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu), as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used device was returned.The ¿funnel¿ end of the catheter was disconnected from the catheter tubing.Adhesive appeared to be present.Upon measuring the returned device, the device measured within specification.Cook has concluded that the device was manufactured to specification additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot 14013265 found no additional complaints or non-conformances.Lot ic13770883 and ic13770885 has a possible related nonconformance.This step is checked 100% per qc.All nonconforming devices were scrapped prior to further processing.Sub-assembly lots sa13465984, sa13555803, sa13745411, and sa13836699 revealed no recorded non-conformances relevant to the failure mode.Based on the available information, cook has concluded that there is no evidence of nonconforming material in house or in the field.Cook requested a supplier investigation be performed for lots (2080966.1, 2095064.1, 2127283.1, 2127284.1, 2128041.1, and 2128973.1).The supplier performs visual, dimensional, and tensile testing on a sampling basis to evaluate the product.The supplier reviewed the dhr for each affected lot and determined there were related nonconformances.All nonconforming devices were scrapped.The supplier reviewed the photograph of the returned devices similar to the appearance of the product after tensile testing.It appears that the device was subjected to a tensile (pulling) load greater than the bond between the molded hub and extruded tube could withstand.The supplier stated that there are not any indications that the product failed to meet specifications.A tensile load was applied to the device resulting in the separation.Cook also reviewed product labeling.The product ifu, [t_thal_rev11] thal-quick chest tube sets and trays provides the following information to the user related to the reported failure mode: ¿instructions for use 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 relieve resistance before proceeding.Note: it is important to advance the chest tube assembly into the pleural space in the same line as the wire guide.This will make introduction easier and avoid kinking of the wire guide.Note: the distal end of the chest tube inserter should not be advanced beyond the distal end of the wire guide.Remove the wire guide and chest tube inserter, leaving the chest tube in place.Note: it is important that all side ports of the chest tube are positioned within the pleural space.The chest tube can now be sutured to the skin and is ready for use.How supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." there are no relevant instructions/precautions/warnings.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded the cause of event to be component failure unrelated to a manufacturing deficiency.Based on the supplier¿s evaluation, it appears the device was subjected to a tensile (pulling) load greater than the bond between the molded hub and extruded tube could withstand.It is unknown how or when after the device was placed that the failure occurred.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 the patient and/or event 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 13361182
• MDR Text Key: 284508860
• Report Number: 1820334-2022-00119
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002041370
• UDI-Public: (01)00827002041370(17)240608(10)14013265
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2024
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-2400
• Device Lot Number: 14013265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 03/01/2022; 10/10/2022
• Supplement Dates FDA Received: 03/04/2022; 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 78 KG