MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VENAFLO VASCULAR GRAFT

Model Number VLT4046C

Device Problem Leak/Splash (1354)

Patient Problem Unspecified Infection (1930)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 10/2024).

Event Description

It was reported that post-surgical graft implantation in avf, the surgical graft leaked fluid and the patient experienced infection within the hospital.It was further reported that the infection was treated for two weeks with antibiotics and that the surgical graft will remain implanted.The healthcare provider (hcp) will continue to observe the patient's symptoms.The patient is reportedly stable.

• Brand Name: VENAFLO VASCULAR GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9868458
• MDR Text Key: 185229189
• Report Number: 2020394-2020-01957
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741020582
• UDI-Public: (01)00801741020582
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K052282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLT4046C
• Device Catalogue Number: VLT4046C
• Device Lot Number: VTDX0456
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• 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): Other