MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LT HEMODIALYSIS CATHETER 14.5F

Catalog Number 5833690

Device Problem Leak/Splash (1354)

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

Event Date 09/12/2014

Event Type  malfunction  

Event Description

It was reported there was a leakage of catheter extension where the clip was placed.

Manufacturer Narrative

A lot history review (lhr) of rexh2115 showed one other similar product complaint(s) from this lot number.The device has not been returned to the mfr, at this time, for eval.

• Brand Name: HEMOSTAR LT HEMODIALYSIS CATHETER 14.5F
• Manufacturer (Section D): BARD ACCESS SYSTEMS; salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque induistrtial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116 ; 80122469
• MDR Report Key: 4352922
• MDR Text Key: 5220335
• Report Number: 3006260740-2014-00611
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2014

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
• Device Catalogue Number: 5833690
• Device Lot Number: REXH2115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• 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
• Patient Age: 29 YR
• Patient Weight: 50