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

Model Number	G56535
Medical Device Problem Codes	Unraveled Material (1664); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: site manager 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 wire included in the wayne pneumothorax set kinked and began to unravel upon removal during a chest tube insertion for a patient of undisclosed age and gender.The user noted that resistance was experienced during chest tube placement.Additional information regarding event details and patient outcome have been requested but are currently unavailable.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation it was reported that the wire included in the wayne pneumothorax set kinked and began to unravel upon removal during a chest tube insertion for a patient of undisclosed age and gender.The user noted that resistance was experienced during chest tube placement.No adverse effects or additional procedures for the patient were reported.Reviews of the complaint history, device history record (dhr), quality control, specifications, 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 dhrs for the reported complaint device lot and the related subassembly lots revealed four non-conformances in which 20 devices were scrapped due to offset coils.A complaint history 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 the field.Cook also reviewed product labeling.The ifu, [c_t_waynemod_rev5] ¿wayne pneumothorax set for seldinger placement¿, packaged with the device contains the following in relation to the reported failure mode: instructions for use ¿7.Attach plastic three-way stopcock to the catheter obturator.Fully straighten the curved catheter tip by advancing the catheter obturator.When fully advanced, attach the obturator to the catheter via the luer lock connection.8.Advance the catheter over the wire guide into the pleural cavity to the desired depth.9.Remove the wire guide and catheter obturator.¿ based on the information provided, no product returned, and the results of the investigation, cook concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.It is unknown if the wire was withdrawn while inside the needle or if the patient had tortuous anatomy.Both could have caused damage to the wire guide resulting in the resistance and uncoiling.However, these possibilities cannot be confirmed.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.

• 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: 19552332
• Report Number: 1820334-2024-00815
• Device Sequence Number: 4811351
• Product Code: JOL
• UDI-Device Identifier: 00827002565357
• UDI-Public: (01)00827002565357(17)231126(10)14505972
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 11/26/2023
• Device Model Number: G56535
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497-IMH
• Device Lot Number: 14505972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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