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

Model Number G52544

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 12/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation = non-healthcare professional- distributor.Pma/510(k) number = k160884.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during inspection within a distribution facility, foreign matter described as a piece of black hair was found inside the cxi support catheter package.The device did not make contact with any patient.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during inspection within a distribution facility, foreign matter described as a piece of black hair was found inside the cxi support catheter package.The device did not make contact with any patient.Investigation evaluation: a review of the complaint history, device history record, documentation, quality control, and visual inspection of photos was conducted during the investigation.The device was not returned to cook for analysis; however, the customer provided photos which show a black fiber visible inside the sealed packaging of the device.A document-based investigation evaluation was performed.There were no related non-conformances or additional complaints found on the lot.Given this information, there is no evidence to suggest that additional non-conforming product exists in-house or in the field.Cook reviewed the packaging final inspection procedure and it was confirmed that there are adequate inspection steps in place to identify foreign matter prior to release.Cook also reviewed product labeling.The product ifu instructs the user to inspect the product to ensure no damage has occurred upon removal from the package and not to use the product if there is doubt as to whether the product is sterile.Based on the information provided and the results of the investigation, cook has concluded that the most likely cause for this event can be traced to manufacturing; however, as there are no other complaints or non-conformances on the lot, the incident was most likely isolated to a single unit.The quality controls in place were also reviewed, it was concluded that there are sufficient inspection steps in place to prevent this from occurring in the future.The risk analysis for this failure mode was reviewed and no additional escalation was 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
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9595751
• MDR Text Key: 177374421
• Report Number: 1820334-2020-00133
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002525443
• UDI-Public: (01)00827002525443(17)221007(10)10065519
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

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
• Device Operator: No Information
• Device Expiration Date: 10/07/2022
• Device Model Number: G52544
• Device Catalogue Number: CXI-4.0-35-150-P-NS-0
• Device Lot Number: 10065519
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1