MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC BARD GLIDEPATH LONG TERM HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 5393230

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 02/14/2019

Event Type  malfunction  

Event Description

When cath lab tech was attaching the tunneler to the catheter, the tip broke off.This was during set up and did not touch a patient.

• Brand Name: BARD GLIDEPATH LONG TERM HEMODIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC; 605 north 6500 west; salt lake city UT 84116
• MDR Report Key: 8459757
• MDR Text Key: 140443495
• Report Number: MW5085259
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 5393230
• Device Catalogue Number: 5393230
• Device Lot Number: RECX0653
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1