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

Model Number	G35089
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/22/2015
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 the cook turbo-flo hd hemodialysis catheter was being used for continuous renal replacement therapy through the right subclavian.The dilator tip broke during insertion.However, the product problem did not result in any device pieces being left within the patient or other serious injuries.

• Brand Name: COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7523097
• Report Number: 1820334-2018-01480
• Device Sequence Number: 18900837
• Product Code: MPB
• UDI-Device Identifier: 00827002350892
• UDI-Public: (01)00827002350892(17)161029(10)5401086
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: G35089
• Device Catalogue Number: C-HDCSYJ-1201J-CCT
• 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: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1