MAUDE Adverse Event Report: COOK INC COOK PNEUMOTHORAX SET; JOL, CATHETER AND TIP, SUCTION

Model Number	G03302
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.D3: country: united states e1: country: united kingdom g1: contact office country: united states g1: manufacturing site country: united states 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 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
It was reported that a cook pneumothorax set was placed in a patient to treat a pneumothorax.Later, the catheter "snapped" when the patient moved positions.Photos provided by the customer show the catheter was secured to the patient with a transparent post-operative adhesive dressing.The photos show the hub separated from the catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.It was reported that a cook pneumothorax set was placed in a patient to treat a pneumothorax.Later, the catheter "snapped" when the patient moved positions.Photos provided by the customer show the catheter was secured to the patient with transparent post-operative adhesive dressing.The photos show the hub separated from the catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, device history record (dhr), quality control procedures and instructions for use were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the dhr for the reported complaint device lot 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: this product is supplied with an instructions for use (ifu) pamphlet, c_t_tpt_rev11.Instructions for use: 6.Attach the catheter to the chest with adhesive tape and skin suture.How supplied: upon removal form package, inspect the product to ensure no damage has occurred.Evidence gathered upon review of the dmr, dhr, ifu and no product return, cook was not able to find evidence suggesting the product was manufactured out of specification.Cook was not able to find evidence of nonconforming product in house or in the field.Based on the information provided, no product returned, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing deficiencies contributed to the reported event.If enough force was placed on the hub of the catheter, it is possible for the hub to separate from the shaft of the device.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: COOK PNEUMOTHORAX SET
• Common Device Name: JOL, CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN
• 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: 21326728
• Report Number: 1820334-2025-00118
• Device Sequence Number: 8697122
• Product Code: JOL
• UDI-Device Identifier: 00827002033023
• UDI-Public: (01)00827002033023(17)260607(10)16128043
• 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
• Report Date (Section B): 05/05/2025

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: 06/07/2026
• Device Model Number: G03302
• Device Catalogue Number: C-TPT-200
• Device Lot Number: 16128043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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