MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 5913230

Device Problem Sticking (1597)

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

Event Date 06/04/2018

Event Type  malfunction  

Event Description

The wire was stuck in the access needle and would not pull through.

• Brand Name: EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 7613653
• MDR Text Key: 111490051
• Report Number: 7613653
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2018,06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5913230
• Device Catalogue Number: 5913230
• Device Lot Number: REBZ1903
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1