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

Model Number	G02092
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation: unknown.Pma/510(k) #: not exempt, pre-amendment.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that upon inspection, the primary packaging of a radial artery pressure monitoring set was found to be damaged.More specifically, there was a hole observed in the back of the package.The device did not make patient contact; therefore, no adverse effects have been reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.A brazilian distributor informed cook that the packaging of a c-pms-400-ra (radial artery pressure monitoring set) from lot 9550100 was punctured.The hole was found on 18oct2019 during an inspection.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control, as well as a visual inspection of photos 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 device showed a small puncture in the white tyvek cover.Based on the information provided, cook did not confirm that 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 there are sufficient inspections in place to address this failure mode prior to distribution.A review of the design history file found that this product is both safe and effective for its intended use.A review of the dhr for the reported complaint device lot (9550100) revealed no recorded non-conformances.A database search did not reveal any other events associated with the reported device lot.Based on this information, cook concluded that there is no evidence suggesting that nonconforming product exists either in house or in field.Based on the information provided, no product returned, and the results of the investigation, a root cause can likely be traced to transport/storage.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: 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: 9273629
• Report Number: 1820334-2019-02768
• Device Sequence Number: 19306057
• Product Code: DQO
• UDI-Device Identifier: 00827002020924
• UDI-Public: (01)00827002020924(17)220225(10)9550100
• 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): 04/30/2020

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: 02/25/2022
• Device Model Number: G02092
• Device Catalogue Number: C-PMS-400-RA
• Device Lot Number: 9550100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1