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

Model Number	N/A
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 a strand of hair was identified inside of the sealed packaging of a wayne pneumothorax set during inspection by the distributor.The complaint device did not make patient contact.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: h6 (medical device problem code - annex a) investigation ¿ evaluation it was reported that a strand of hair was identified inside of the sealed packaging of a wayne pneumothorax set during inspection by the distributor.The complaint device did not make patient contact.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures for the device, as well as a visual inspection of a customer provided photo, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.The customer did provide pictures of the hair-like fiber inside the packaging.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the dhr for the complaint lot and records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.An expanded dhr was performed.Additional related lots were reviewed, and no additional complaints were reported from the field.There were related non-conformances but there are 100% inspections in place to identify these failures before shipping and all non-conforming material was scrapped.There is no evidence that additional non-conforming product exists in house or in the field.The information provided upon review of provided photos indicates the device was manufactured out of specification.However, based on review of the device master record, product labeling, device history record, and device failure analysis, there is no evidence of additional 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 the customer provided photo, and the results of the investigation, cook has concluded a manufacturing/quality control deficiency is the cause of this failure.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: 17377917
• Report Number: 1820334-2023-00954
• Device Sequence Number: 6506519
• Product Code: JOL
• UDI-Device Identifier: 00827002565326
• UDI-Public: (01)00827002565326(17)241201(10)14851956
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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
• Device Expiration Date: 12/01/2024
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1020-WAYNE-IMH
• Device Lot Number: 14851956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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
• Patient Sex: Unknown