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 Patient Involvement (2645)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during inspection of a wayne pneumothorax set at a distribution facility in (b)(6), an unidentified particle was observed inside the primary packaging of the product.No patient contact was made and no other adverse effects have been reported for this incident.
Event or Problem Description
No additional patient/event details have been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.(b)(6) from agility logistics informed cook on 25nov2019 of an incident involving a wayne pneumothorax set [rpn: (b)(4)] from lot number ns9856121.On 01nov2019 during inspection an unidentified particle was observed inside the primary packaging of the product.A review of the complaint history, device history record, instructions for use (ifu), and quality control were conducted during the investigation.The visual inspection of the complaint device could not be completed as the device was not returned for evaluation.Cook received images of the device showing a sealed package for rpn (b)(4) and lot ns9856121.There is a piece of hair identified within the sealed pouch.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file found that adequate risk controls are in place to capture this potential failure mode before distributing the product to the customer.A review of the device history record for this device lot recorded no related nonconformances or additional complaints.There is no evidence to suggest there is any nonconforming product in house or out in the field.A review of the product labeling for the device was also completed.The instructions for use state the following instructions related to the reported failure mode: how supplied: -¿do not use the product if there is doubt as to whether the product is sterile.¿.Based on the information provided, no inspection of the product, and the results of the investigation, a definitive cause was established as a manufacturing/quality control deficiency.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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
• MDR Report Key: 9444681
• Report Number: 1820334-2019-03069
• Device Sequence Number: 2093909
• Product Code: JOL
• UDI-Device Identifier: 00827002565333
• UDI-Public: (01)00827002565333(17)210714(10)NS9856121
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: No Information
• Device Expiration Date: 07/14/2021
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-IMH
• Device Lot Number: NS9856121
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1