MAUDE Adverse Event Report: COOK INC RADIAL ARTERY PRESSURE MONITORING SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.Pma/510(k) #: pre-amendment.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 unidentifiable particles were found in the primary packaging of two radial artery pressure monitoring sets from the same lot.The particles were found by a third party distributor.The devices did not make patient contact.
Event or Problem Description
No additional information regarding the event has 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 a review of the complaint device photos, complaint history, device history record, and quality control were conducted during the investigation.The device was not returned, but the customer provided photos of the complaint device.A particle of foreign matter is visible within the sealed packaging of the devices.Additionally, a document based investigation evaluation was performed.The device master record showed sufficient controls are in place to address this failure mode, including inspecting all package seals, examining each seal for defects and foreign matter, and ensuring each seal is solid and smooth.A review of the device history record showed no nonconformances.There are no related nonconformances or other complaints from this lot so there is no evidence that nonconforming product exists in house or in the field.Based on the information provided, no returned product, and the results of the investigation, the root cause was traced to manufacturing, specifically a 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: RADIAL ARTERY PRESSURE MONITORING SET
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8768401
• Report Number: 1820334-2019-01630
• Device Sequence Number: 16638629
• Product Code: DQO
• UDI-Device Identifier: 00827002029262
• UDI-Public: (01)00827002029262(17)220306(10)9571454
• 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): 08/23/2019

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: 03/06/2022
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-250-RA
• Device Lot Number: 9571454
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1