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

Catalog Number	CXI-2.6-18-150-P-NS-ANG
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that a white foreign matter, such as paper, was found on the tip of the cxi support catheter when the device package was opened.The procedure was completed with a similar device.No patient contact was made with the complaint device.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.No images were provided for review.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.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 complaints for this lot number that could contribute to this failure mode.Per manufacturing quality control documentation, "inspect all package seals (end seals, side seals, and chevron seal if applicable).Examine each seal for defects, foreign matter (dirt, hair, paper, fuzz, etc.).Product must be free of any visible cuts, holes, or foreign matter." based on the information provided, no product returned, and the results of our investigation, the root cause for the foreign matter was determined to be related to manufacturing.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: CXI SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7155262
• Report Number: 1820334-2017-04580
• Device Sequence Number: 1274773
• Product Code: KRA
• UDI-Device Identifier: 00827002500037
• UDI-Public: (01)00827002500037(17)200816(10)8145768
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: Health Professional
• Device Catalogue Number: CXI-2.6-18-150-P-NS-ANG
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1