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

Model Number	N/A
Medical Device Problem Codes	Leak/Splash (1354); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a chest drain valve in wayne pneumothorax set leaked.The device was placed by micro-puncture in the pleural cavity for drainage of air and fluid and was securely connected to a collection bag.Two days later leakage was discovered at the distal end of the chest drain valve.It was noted that no force had been exerted on the catheter.Further communication with the customer indicated that the physician was concerned about contamination; therefore, the entire chest drain system was removed and replaced.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Initial reporter, customer (person): postal code: (b)(6); phone: (b)(6); e-mail: (b)(6).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.
Additional Manufacturer Narrative
Investigation ¿ evaluation: it was reported that a chest drain valve in wayne pneumothorax set (rpn: c-utpt-1400-wayne-imh; lot#: 13627273) leaked.The device was placed by micro-puncture in the pleural cavity for drainage of air and fluid and was securely connected to a collection bag.Two days later, leakage was discovered at the distal end of the chest drain valve.A photo provided by the customer shows the clear portion of the chest drain valve has separated from the blue end.It was noted that no force had been exerted on the catheter.Further communication with the customer indicated that the physician was concerned about contamination; therefore, the entire chest drain system was removed and replaced.No other adverse effects were reported for this incident.Reviews of documentation including complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures of the complaint device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, the customer provided photos of the chest drain valve being opened/separated.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.Cook reviewed the dhr for the reported complaint device lot 13627273.There were no related non-conformances or additional complaints found.Cook requested that the supplier investigate this occurrence.The supplier reviewed the lot records for this device.No nonconforming devices were noted.A review of the section data did not reveal any anomalies during production.There are no indications of a manufacturing issue that contributed to this failure mode.A vacuum decay test is performed on 100% of these products.Cook also reviewed product labeling.The product ifu, [c_t_wayne _rev12] ¿wayne pneumothorax set for trocar placement,¿ provides the following information to the user related to the reported failure mode: ¿instructions for use -preassemble catheter, 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.Do not connect catheter directly to wall suction.-remove obturator and confirm placement by valve movement and fluoroscopic or roentgenographic verification.All connections must be secure and airtight.Perform inspections of the catheter and connections regularly.The catheter and connected drain lines should be secured to the patient.Excessive tension on catheter connections (e.G., in instances of patient movement where the catheter in connected to a vacuum or drainage collection apparatus) may cause catheter/hub separation or accidental catheter dislodgement.To help prevent this from occurring, it is recommended to do one or both of the following: secure the catheter hub to the patient¿s skin by placing tape, suture, or a catheter securement device at the location.Form a strain relief loop in the connecting tube and secure the loop to the patient¿s skin with tape, suture, or catheter securement device.How supplied: supplied sterilized 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.¿ based on the device history record, supplier investigation, device master record, and product labeling, there is no indication the complaint device was manufactured out of specification.Cook did not identify any nonconforming material in house or in the field.Based on the information provided, no product returned, and the results of the investigation, cook concluded the cause of event to be component failure unrelated to manufacturing deficiency.The customer stated there was a problem with the one-way valve fitting.The chest drain valve opened, and it was not possible to fix it.It is possible that patient movement could have contributed to the reported failure; however, we cannot confirm this without additional information.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.
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: 16375174
• Report Number: 1820334-2023-00133
• Device Sequence Number: 7543793
• Product Code: JOL
• UDI-Device Identifier: 00827002565333
• UDI-Public: (01)00827002565333(17)220926(10)13627273
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2022
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-IMH
• Device Lot Number: 13627273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2020
• 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
• Patient Age: 45 YR
• Patient Sex: Male