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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH
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CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH Back to Search Results
Catalog Number CXI-4.0-35-90-P-NS-DAV
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/19/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
It was noted that another manufacturer's guide wire didn't exit at the end of the cxi catheter but was running beside the catheter from the level of a radiopaque marker.It was further noted that the catheter was separated and there was a small hole in the catheter material.There were no reported adverse effects to the patient as a result of this product problem.
 
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Brand Name
CXI SUPPORT CATHETER
Common Device Name
KRA CATHETER, CONTINUOUS FLUSH
MDR Report Key6991331
Report Number1820334-2017-03406
Device Sequence Number11085912
Product Code KRA
UDI-Device Identifier00827002525474
UDI-Public(01)00827002525474(17)170401(10)4936083
Combination Product (Y/N)N
Initial Reporter CountryAU
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/31/2017
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 NumberCXI-4.0-35-90-P-NS-DAV
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/27/2017
Initial Report FDA Received Date10/31/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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