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

Model Number	G56550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Name and address - postal code: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 or Problem Description
As reported, prior to an unspecified procedure, a cxi support catheter was opened and the tip was found separated in the packaging.There was no damage to the packaging noted.A new same type device from a different lot was used to complete the procedure.The complaint device did not make contract with the patient and there has been no health hazard reported.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Summary of event: as reported, prior to an unspecified procedure, a cxi support catheter was opened, and the tip was found separated in the packaging.There was no damage to the packaging noted.A new same type device from a different lot was used to complete the procedure.The complaint device did not make contact with the patient and there has been no health hazard reported.Investigation evaluation: reviews of the complaint history, device history record, manufacturing instructions, and quality control procedures were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.In response to this incident, cook reviewed the device history record.The dhr for the reported lot number recorded no relevant non-conformances.The dhr on subassembly lots recorded two relevant non-conformances; however, all non-conforming product was scrapped and there are 100% inspections in place to capture this non-conformance.A review of complaint history records shows no other relevant complaints associated with the complaint device lot.The instructions for use (ifu) states "upon removal from package, inspect the product to ensure no damage has occurred." cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr and ifu suggests that there is evidence the complaint device was manufactured out of specification.Although two relevant non-conformances were noted on sub-assembly lots, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other relevant complaints have been received from the field for this lot.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in house or in the field.Based on the available information and results of the investigation, cook has concluded that a manufacturing deficiency contributed to this incident.The risk analysis for this failure mode was reviewed and no additional escalation is required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.

• Brand Name: CXI SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16589625
• Report Number: 1820334-2023-00287
• Device Sequence Number: 20068032
• Product Code: KRA
• UDI-Device Identifier: 00827002565500
• UDI-Public: (01)00827002565500(17)241014(10)14276907
• Combination Product (Y/N): N
• PMA/510(K) Number: K122796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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: 10/14/2024
• Device Model Number: G56550
• Device Catalogue Number: CXI-2.6-18-90-0
• Device Lot Number: 14276907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown