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

Catalog Number C-PMS-400-RA

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a particle of foreign material was observed in the unopened sterile packaging of a radial artery pressure monitoring set during incoming inspection.The device did not make patient contact.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Corrected data: device evaluation: the complainant did not return the complaint device to the manufacturer for investigation.However, a set of photos provided from the customer confirmed there was a foreign matter particle in the unopened packaging, towards the distal end.This confirms that the device was not packaged to specification.Investigation: a document-based investigation reviewed the following: complaint history, device history record, instructions for use, and quality control specifications.A review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.¿how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ conclusion: based on the information provided, examination of the device photos, and the results of our investigation, the root cause was determined as cause traced to manufacturing (quality control deficiency).Per the [quality engineering] risk assessment, no further action is required.Appropriate measures were initiated to address this failure mode.As a result, there are new gowning procedures in place that should prevent this failure.The appropriate personnel will be notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8192293
• MDR Text Key: 131332522
• Report Number: 1820334-2018-03709
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002020924
• UDI-Public: (01)00827002020924(17)210322(10)8687443
• 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: 02/28/2019

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
• Device Operator: No Information
• Device Expiration Date: 03/22/2021
• Device Catalogue Number: C-PMS-400-RA
• Device Lot Number: 8687443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1