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

Model Number G35102

Device Problems Bent (1059); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2015

Event Type  malfunction  

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 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7522942
• MDR Text Key: 108799543
• Report Number: 1820334-2018-01479
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00827002351028
• UDI-Public: (01)00827002351028(17)161204(10)5398702
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G35102
• Device Catalogue Number: C-HDCSYJ-1201J-LSC-CCT-A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1