MAUDE Adverse Event Report: COOK INC COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

Model Number	G35098
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name: mpb catheter, hemodialysis, non-implanted.Product code: mpb.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
The complainant reported that a central line was being placed on the right side of the patient's neck, and the dilator frayed at the distal end after threading the dilator over the provided guide wire.The dilator was removed from the body without any further issues and there were no reported serious injuries to the patient as a result of the product problem.

• Brand Name: COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7525517
• Report Number: 1820334-2018-01482
• Device Sequence Number: 1550379
• Product Code: MPB
• UDI-Device Identifier: 00827002350984
• UDI-Public: (01)00827002350984(17)170930(10)5668982
• 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
• Report Date (Section B): 05/18/2018

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 Model Number: G35098
• Device Catalogue Number: C-HDCSY-1201J-CCT-A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1