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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unidentified particle was discovered inside of the sealed packaging of a wayne pneumothorax set during stock inspection of the product.No harm has been reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Investigation ¿ evaluation: ((b)(6) (brazil) informed cook that on 17apr2023 an unidentified particle was discovered inside of the sealed packaging of a wayne pneumothorax set (rpn: c-utpt-1400-wayne-imh; lot: 15301780) during stock inspection of the product.No patient contact was reported.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu) 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 did provide a photo showing the particle inside the packaging.The particle did not appear to be in the seal.Based on this information, the device was manufactured out of specification.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.A review of the dhrs for the reported complaint device lot 15031780 and the related subassembly lots revealed no related non-conformances.A database search found no additional complaints reported from this lot.There is no evidence of nonconforming material in house or in the field.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: how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, review of photo, and the results of the investigation, cook concluded the cause of this event is manufacturing and quality control deficiency.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: 16794681
• Report Number: 1820334-2023-00487
• Device Sequence Number: 3237610
• Product Code: JOL
• UDI-Device Identifier: 00827002565333
• UDI-Public: (01)00827002565333(17)240924(10)15031780
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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
• Device Expiration Date: 09/24/2024
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-IMH
• Device Lot Number: 15031780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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