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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH
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COOK INC CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH Back to Search Results
Catalog Number CXI-2.6-18-150-P-NS-0
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/16/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol_cap(b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
The physician confirmed that the catheter had a kink near the hub before flushing the device.According to the physician, there was no kink when the device was removed from the package.Visual exam of the device noted stretching near the hub.Another device of different size was used instead.
 
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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 Key6992676
Report Number1820334-2017-03832
Device Sequence Number1183883
Product Code KRA
UDI-Device Identifier00827002500013
UDI-Public(01)00827002500013(17)171203(10)5487162
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/01/2017
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-2.6-18-150-P-NS-0
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 Date11/01/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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