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

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Dyspnea (1816); Increased Respiratory Rate (2486); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the obturator of a wayne pneumothorax set was left inside the catheter.The patient underwent the procedure of chest tube placement for the management of pneumothorax in the emergency room (er) on (b)(6) 2024.After the device was placed inside the patient it appeared to be in good condition and was "leaking air"; however, it was minimal.A chest x-ray was taken which showed improvement.However, the patient later experienced severe subcutaneous emphysema, swelling of the face and upper body, and increasing dyspnea and tachypnea requiring oxygen by nasal tube.Late in the evening of (b)(6) 2024, the patient still had dyspnea, and "no air was leaking".The catheter was inspected in the er with a pulmonary department nurse.Upon inspection of the device, it was discovered that the gray obturator was left in the catheter which obstructed the lumen and prevented the device from functioning properly.The obturator was removed, and the problem was solved.The patient received a computed tomography (ct) scan and a visit from a pulmonologist fellow on (b)(6) 2024 due to this event.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
E1 - customer (person): postal code: (b)(6).G4 ¿ pma/510(k) #: exempt.H6 - annex e: e2402 - appropriate term / code not available was selected to capture "subcutaneous emphysema".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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: h6 - annex g investigation ¿ evaluation it was reported that the obturator of a wayne pneumothorax set was left inside the catheter.The patient underwent the placement of a chest tube for a pneumothorax in the emergency room (er) on (b)(6) 2024.After the device was placed inside the patient, it appeared to be in good condition and was "leaking air"; however, it was minimal.A chest x-ray was taken which showed improvement.However, the patient later experienced severe subcutaneous emphysema, swelling of the face and upper body, and increasing dyspnea and tachypnea requiring oxygen by nasal tube.Late in the evening of (b)(6) 2024, the patient still had dyspnea, and "no air was leaking".The catheter was inspected in the er by a pulmonary department nurse.Upon inspection of the device, it was discovered that the gray obturator was left in the catheter which obstructed the lumen and prevented the device from functioning properly.The obturator was removed, and the problem was solved.The patient received a computed tomography (ct) scan and a visit from a pulmonologist fellow on (b)(6) 2024 due to this event.No other adverse effects were reported for this incident.Reviews of 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 any potential non-conformances prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A complaint history search found one additional complaint associated with the reported device lot; however, it is not related to the report complaint event.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 instructions for use (ifu) [c_t_waynemod_rev5] supplied 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.Depth may be guided by the 2.5 cm markings on the catheter.The first mark begins 5 cm from the last side hole.9.Remove the wire guide and catheter obturator.Attach catheter to connecting tube with stopcock and cook chest drain valve.Attach cook chest drain valve in direction indicated by arrow on valve.Note: chest drain valve may be obviated if catheter is to be connected to a water seal suction apparatus or similar mechanical suction device.¿ based on the available information, no product returned, and the results of the investigation, the cause of this complaint is failure to follow instructions.There are instructions in the ifu as well as a label on the obturator instructing the user to remove the obturator from the catheter.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: 18720096
• Report Number: 1820334-2024-00222
• Device Sequence Number: 3314690
• Product Code: JOL
• UDI-Device Identifier: 00827002565357
• UDI-Public: (01)00827002565357(17)241211(10)15281339
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2024
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497-IMH
• Device Lot Number: 15281339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/25/2024; 05/07/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/26/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male