MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROVIAC CV CATHETER 2.7F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	0600044
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/08/2016
Type of Reportable Event	Serious Injury
Additional 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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rezh0902 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Nurse reported that a two month old patient had a broviac placed in the right saphenous vein on (b)(6) 2016.On (b)(6) 2016 an x-ray was taken and it was noted that a piece of the catheter had broken inside the patient and had migrated to the left pulmonary artery.Physicians reviewed past x-rays taken and determined that the catheter broke on (b)(6).They initially thought the piece was part of the leads from the patient's permanent pace maker.The reported broken piece was removed but the line currently remains in patient.The nurse stated that the line will be replaced in the future.

• Brand Name: BROVIAC CV CATHETER 2.7F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5552875
• Report Number: 3006260740-2016-00151
• Device Sequence Number: 248839
• Product Code: LJS
• UDI-Device Identifier: 00801741036316
• UDI-Public: (01)00801741036316(17)200728(10)REZH0902
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 0600044
• Device Lot Number: REZH0902
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 MO