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

Model Number	G56535
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information was provided 17dec2024.The clear body was not separated from the blue hub.The device was secured to the patient using suture.There was nothing attached to the chest drain valve.After the leak was discovered, they removed the valve and replaced it with a conical fitting.
Additional 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.
Additional Manufacturer Narrative
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 the chest drain valve of a wayne pneumothorax set leaked.A leak in the chest drain valve was discovered after placing the chest drainage catheter in an unknown patient.The chest drain valve was changed and replaced by a new one via "biconical connection".As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event has been requested but is currently unavailable.
Additional Manufacturer Narrative
Additional information: d9 - device available for evaluation; h3 - device evaluated by mfg?: device not returned to manufacturer.Investigation ¿ evaluation.It was reported that the chest drain valve from a wayne pneumothorax set leaked.The chest drainage catheter was placed in an unknown patient and was secured with suture.There was nothing attached to the chest drain valve.Later, a leak in the chest drain valve was discovered.The clear body was not separated from the blue hub.As a result, the chest drain valve was removed and replaced with a conical fitting.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control, and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 dhr for the reported complaint device lot and related raw material lots revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook requested a supplier investigation as the component is supplied to cook.The supplier did not identify any non-conforming material and was not able to establish a cause for failure.Cook also reviewed product labeling.The ifu supplied with the device states the following in consideration of the reported failure mode: ¿10.Confirm catheter placement by valve movement and fluoroscopic or roentgenographic verification.All connections must be secure and airtight.Perform inspections of the catheter and connections regularly.¿ based on the available information, no product returned, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.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 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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: WAYNE PNEUMOTHORAX SET
• Common Device Name: JOL CATHETER AND TIP, SUCTION
• 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: 20917687
• Report Number: 1820334-2024-01636
• Device Sequence Number: 5129629
• Product Code: JOL
• UDI-Device Identifier: 00827002565357
• UDI-Public: (01)00827002565357(17)260819(10)16249233
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2025

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: 08/19/2026
• Device Model Number: G56535
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497-IMH
• Device Lot Number: 16249233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 04/07/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 12/23/2024; 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2024
• 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