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

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(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.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.Investigation summary: a review of the sterilization records and bioburden identified that the lot met all sterile release criteria and no unacceptable bioburden results were identified.A lot sample was returned and tested using the wep tester at 3.5psi.No water was observed to be leaking from the device.Based on the available information, the most likely root cause is patient and/or procedural related.The investigation is inconclusive.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

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
• MDR Report Key: 9869368
• MDR Text Key: 185228912
• Report Number: 2020394-2020-01964
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741020582
• UDI-Public: (01)00801741020582
• Combination Product (y/n): N
• PMA/PMN Number: K052282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VLT4046C
• Device Catalogue Number: VLT4046C
• Device Lot Number: VTDX0456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEFTRIAXONE; CEFTRIAXONE; GENTAMICINE; GENTAMICINE
• Patient Outcome(s): Other