MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. LEONARD 10 FR DL CVC, PEEL-APART INTRODUCER KIT

Catalog Number 7617405

Device Problem Mechanics Altered (2984)

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

Event Date 09/15/2014

Event Type  malfunction  

Event Description

It was reported that sandholes appeared at 23cm from the catheter after it was being used for 1 month.

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of rexg2001 showed three other similar product complaint(s) from this lot number.All complaints for this lot number (rexg2001) have been reported from two (b)(6) facilities.

• Brand Name: LEONARD 10 FR DL CVC, PEEL-APART INTRODUCER KIT
• 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 84116-0000 ; 8015224969
• MDR Report Key: 4173537
• MDR Text Key: 5091846
• Report Number: 3006260740-2014-00509
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K830233
• 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: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7617405
• Device Lot Number: REXG2001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• 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