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

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #: pre-amendment.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a "strange particle" was found inside the primary packaging of a radial artery pressure monitoring set.No patient contact was made as the issue was noticed before the product was opened.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation ¿ evaluation: 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 investigation.Images of the complaint device were provided by the complainant.Examination of the images showed a piece of foreign matter inside the package.There is evidence to suggest that the product was not manufactured to current specifications.Because foreign matter was observed in the package the complaint can be confirmed on the customer provided images.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 concluded 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 found no non-conformances for this lot, and a trackwise search on this lot found no additional complaints.There is no evidence to suggest there is any nonconforming product in house or out in the field.Based on the information provided, no inspection of the product, and the results of the investigation, a definitive cause was established as a manufacturing issue traced to 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.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: RADIAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8983352
• MDR Text Key: 157471657
• Report Number: 1820334-2019-02263
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002020924
• UDI-Public: (01)00827002020924(17)211106(10)9291339
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/06/2021
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-400-RA
• Device Lot Number: 9291339
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1