MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F

Catalog Number 5704150

Device Problems Collapse (1099); No Flow (2991)

Patient Problem Cyanosis (1798)

Event Type  Injury  

Event Description

It was reported that the catheter has been placed in left jugular for dialysis in (b)(6) 2014.It was reported a flow problem on venous branch (blue way).The blue way collapses and there is more blood flow.

Manufacturer Narrative

A lot history review (lhr) of reye0707 showed no other similar product complaint(s) from these lot numbers.The device has not been returned to the manufacturer, at this time, for evaluation.

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F
• Manufacturer (Section D): BARD ACCESS SYSTEMS INC.; salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116 ; 8015224969
• MDR Report Key: 4697011
• MDR Text Key: 5677889
• Report Number: 3006260740-2015-00157
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K030020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 5704150
• Device Lot Number: REYE0707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention