MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROVIAC 4.2 FR SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number 0600520

Device Problems Kinked (1339); Split (2537); Improper Flow or Infusion (2954)

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

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The original sample was discarded at the facility.A lot history review (lhr) of huzf0163 showed no other similar product complaint(s) from this lot number.The original sample was discarded at the facility.

Event Description

It was reported that the catheter damage was observed soon after the placement.The placement of catheter was completed in the operating room on (b)(6) 2016.After that, a nurse secured the catheter without stabilizing it by dressing and moved the patient to the hospital ward.A little later, just before the injection was started, the blood backflow and the split on the catheter was found.So, the operator removed the catheter from the patient body.The second layer of the catheter was seemed to be damaged and the first layer (the innermost layer) was kinked according to the detailed observation by the facility.The patient could not move his body, so there was little possibility that the catheter was damaged due to the physical movements of the patient.

• Brand Name: BROVIAC 4.2 FR SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 6713858
• MDR Text Key: 80140029
• Report Number: 3006260740-2017-01047
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807(10)HUZF0163
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K830256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600520
• Device Catalogue Number: 0600520
• Device Lot Number: HUZF0163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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 Age: 3 YR