MAUDE Adverse Event Report: COOK INC CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH

Catalog Number CXI-2.6-18-90-P-NS-0

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

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 foreign matter, described as "something like dust," was confirmed inside the unopened cxi support catheter package.The device never made patient contact.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the unused product, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, specifications, and a visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed that foreign matter was present in the lower right corner.Additionally, a document based investigation evaluation was performed.There is evidence to suggest that this device was not made to specification.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Moreover, an ifu is provided with the device, which states ¿do not use the product if there is a doubt as to whether the product is sterile." furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.However, measures are being conducted to address this oversight.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could be traced to manufacturing deficiency.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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.

Event Description

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

• Brand Name: CXI SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8109980
• MDR Text Key: 128568868
• Report Number: 1820334-2018-03485
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002500044
• UDI-Public: (01)00827002500044(17)210919(10)9174293
• Combination Product (y/n): N
• PMA/PMN Number: K072724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/19/2021
• Device Catalogue Number: CXI-2.6-18-90-P-NS-0
• Device Lot Number: 9174293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1