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

Model Number	G35102
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2015
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
It was reported that the doctor was sliding the wire on the wire guide holder then touched the tip and bent it.An edge of the wire became visible.It was further noted that the distal tip of the mandril wire was protruding from the bent coil.This product problem occurred during a demonstration with the turbo-flo hd hemodialysis catheter tray, and there was no patient contact.

• Brand Name: TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7522942
• Report Number: 1820334-2018-01479
• Device Sequence Number: 1694756
• Product Code: MSD
• UDI-Device Identifier: 00827002351028
• UDI-Public: (01)00827002351028(17)161204(10)5398702
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• 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: G35102
• Device Catalogue Number: C-HDCSYJ-1201J-LSC-CCT-A
• Was Device Available for Evaluation?: Yes
• 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