MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DIALYSIS CATHETER; IMPLANTED HEMODIALYSIS CATHETER

Device Problem Torn Material (3024)

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

Event Date 05/01/2014

Event Type  malfunction  

Event Description

It was reported that a tear was noticed in the venous leg of the catheter (outside catheter just aside the hub).A new catheter was placed.

Manufacturer Narrative

A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.The complaint of an external leak is confirmed and will be considered user related.During functional testing a leak was observed emanating from the venous extension tubing.With the tubing relaxed the od surface reveal sharp well-defined edges.Applying tension on both sides of the split site reveals smooth, glossy and striated surfaces indicating partial severance by a sharp instrument such as a knife or surgical scalpel.No mechanical damage is noted to the od of the tubing around the slit site.Despite this, the tubing walls appear uniform in thickness and without any manufacturing defect.No tearing in the tubing was observed during gross and microscopic examinations.Gross visual and microscopic examinations function and tactual testing shows no evidence of a defect or deformity related to the manufacturing process.

• Brand Name: DIALYSIS CATHETER
• Type of Device: IMPLANTED HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; salt lake city UT
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116 ; 8015224969
• MDR Report Key: 3979208
• MDR Text Key: 4635204
• Report Number: 3006260740-2014-00280
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2014

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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