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

Model Number	G04891
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: customer (person): (b)(6).G4 - 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.
Event or Problem Description
It was reported that mold-like foreign matter was found within the sealed packaging of a thal-quick chest tube set.The issue was found in the packaging and did not make patient contact.No harm has currently been reported.Additional information regarding event details has been requested but is currently unavailable.
Event or Problem Description
This event no longer meets the definition of a reportable complaint.See h10.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Correction: the complaint device was received by the manufacturer on 12feb2025 for evaluation.During the preliminary device failure analysis, it was confirmed that there was no mold present, either within the sealed packaging or on the outside of the packaging.There event is no longer reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury and/or reportable product malfunction.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.
Additional Manufacturer Narrative
E1: phone: (b)(6).Additional information: d9 (date returned to manufacturer) correction.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 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 or that a death or serious injury occurred; nor is it admission 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
During the review of the device failure analysis, it was discovered that a very small piece of foreign matter was present in the seal of the device.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation it was reported that mold-like foreign matter was found within the sealed packaging of a thal-quick chest tube set.During the review of the device failure analysis, it was discovered that no mold was identified, but a very small piece of foreign matter was present in the seal of the device.No harm has been reported.Reviews of the documentation, including the complaint history, device history record, quality control procedures, and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One unused/sealed tray was received.No mold was present inside the tray, however there were portions of the seal that appeared to be thinner and discolored, likely due to excessive heat exposure.An unknown piece of foreign matter appeared to be stuck below the seal inside the packaging.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 device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: the product ifu, [c_t_thal_rev11] ¿thal-quick chest tube sets and trays,¿ provides the following information to the user related to the reported failure mode: ¿how supplied supplied sterilize 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.¿ evidence gathered upon review of the returned device indicates the device was manufactured out of specification.However, the review of the dmr and dhr suggests that there are no additional nonconforming devices in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that the cause of the event to be a quality control deficiency.Per the risk assessment no further action is required.The appropriate personnel have been notified.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 information regarding the patient and/or event 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 21057848
• Report Number: 1820334-2025-00004
• Device Sequence Number: 7947699
• Product Code: GBX
• UDI-Device Identifier: 00827002048911
• UDI-Public: (01)00827002048911(17)250927(10)14979286
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2025
• Device Model Number: G04891
• Device Catalogue Number: C-TQTS-1600
• Device Lot Number: 14979286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 02/12/2025; 04/04/2025; 04/09/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/24/2025; 04/10/2025; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown