MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. HEMOGLIDE PC DIALYSIS CATHETER KIT 23CM 14.5F

Catalog Number 5663230

Device Problem Failure to Advance (2524)

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

Event Type  malfunction  

Event Description

During insertion of guidewire, it failed to advance.Product unable to be used.Haemodialysis pt required insertion of permacath as primary access.

Manufacturer Narrative

A lot history review (lhr) of resf0280 showed no other similar product complaint(s) from this lot number.The complaint of a damaged guidewire was confirmed, and the cause appears to be use related.The product returned for eval was a 0.037" guidewire.The sample was returned with the distal end of the outer coil wire be elongated.A complete break was observed on the inner core wire at this region.Microscopic examination of the inner core wire at the break site revealed an uneven break site.This edge of the guidewire also had material necking and a granular fracture surface.The characteristics of the guidewire suggest it underwent a tensile event which appears to have happened during use.

• Brand Name: HEMOGLIDE PC DIALYSIS CATHETER KIT 23CM 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: 4005882
• MDR Text Key: 4712510
• Report Number: 3006260740-2014-00383
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K010567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2013

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
• Device Catalogue Number: 5663230
• Device Lot Number: RESF0280
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2008
• 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