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 0600040

Device Problems Complete Blockage (1094); Mechanics Altered (2984)

Patient Problems Extravasation (1842); Venipuncture (2129)

Event Date 08/02/2015

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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rezf1194 showed one other similar product complaints from this lot number.

Event Description

On (b)(6) 2015 - it was reported per medwatch that after a previous broviac catheter was removed, a second bard broviac catheter was placed into the left greater saphenous vein.Five days later, the catheter was not functional and extravasation was noted.Catheter was removed and was noted to be clotted distally and "blownout" proximally.A third catheter was placed until it was no longer needed.The catheter was removed.On (b)(6) 2015 - additional information received: the third catheter was no longer needed.Facility reported to issues with it.

• Brand Name: BROVIAC CV CATHETER 2.7F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH
• 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 REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 5368782
• MDR Text Key: 36351886
• Report Number: 3006260740-2015-00646
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036309
• UDI-Public: (01)00801741036309(17)200628(10)REZF1194
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2015,12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Catalogue Number: 0600040
• Device Lot Number: REZF1194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2015
• 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: 7 MO
• Patient Weight: 6