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

Model Number	G56533
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 upon inspection, a particle was observed in the primary packaging of a wayne pneumothorax set prior to use.Photos of the device provided by the user facility suggest that the unidentified particle is a loose hair.No patient contact was made and no adverse effects were reported.
Additional Manufacturer Narrative
Investigation - evaluation: it was reported that the packaging of a wayne pneumothorax set (c-utpt-1400-wayne-imh) from lot 10336457 contained an unknown particle inside.Cook became aware of this event on 22may2020 upon being notified by the distributor (b)(4) the device did not reach the user facility.A review of the complaint history, device history record (dhr), instructions for use (ifu) and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, photos of the failure mode were provided to cook by the distributor.In the photos, an unknown fiber can be seen within the unopened packaging of the device.Cook has concluded that there is evidence that the device was not manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) showed that this product is both safe and effective for its intended use.A review of the device history record (dhr) for the reported complaint device lot (10336457) revealed no non-conformances related to the reported failure mode.A database search found no other events associated with the complaint device lot.As there are no related non-conformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.Cook also reviewed product labeling.Instructions for use (ifu) document for wayne pneumothorax set for trocar placement is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿how supplied sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.¿ based on the information provided, no product returned, and the results of the investigation, a definitive root cause for this event has been contributed to a deficiency in manufacturing/quality control.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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 patient/event information 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
• MDR Report Key: 10111631
• Report Number: 1820334-2020-01051
• Device Sequence Number: 3122459
• Product Code: JOL
• UDI-Device Identifier: 00827002565333
• UDI-Public: (01)00827002565333(17)220118(10)10336457
• Combination Product (Y/N): N
• 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): 07/14/2020

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: 01/18/2022
• Device Model Number: G56533
• Device Catalogue Number: C-UTPT-1400-WAYNE-IMH
• Device Lot Number: 10336457
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1