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

Model Number	G50003
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the initial reporter, the device will not be returned.Occupation: unknown.Pma/510(k) number: k160884.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, while flushing the device, prior to patient contact for an unknown procedure, a cxi support catheter was found to be bent.Additional information provided 03 oct 2019 revealed that the device was found to have sharp edges at the kink / bend "because it was so completely crushed".Per the user, the packaging of the device was fine; however, it looked like the front five or six inches of the device would "snap off".A new device of the same type was used to complete the procedure.The device did not make contact with the patient.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.There is no evidence to suggest that the reported device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury and/or product malfunction.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem 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
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9176777
• Report Number: 1820334-2019-02558
• Device Sequence Number: 11673316
• Product Code: KRA
• UDI-Device Identifier: 00827002500037
• UDI-Public: (01)00827002500037(17)220605(10)9788473
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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 Expiration Date: 06/05/2022
• Device Model Number: G50003
• Device Catalogue Number: CXI-2.6-18-150-P-NS-ANG
• Device Lot Number: 9788473
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1