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

Model Number	VLT4046C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: review of the sterilization records and bioburden identified that the lot met all sterile release criteria and no unacceptable bioburden results were identified.Based on the available information, the most likely root cause is patient and/or procedural related.The device was not returned.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 or Problem 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 patient is reported as stable.

• Brand Name: VENAFLO VASCULAR GRAFT
• Common Device Name: VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9869181
• Report Number: 2020394-2020-01960
• Device Sequence Number: 16960915
• Product Code: DSY
• UDI-Device Identifier: 00801741020582
• UDI-Public: (01)00801741020582
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K052282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: VLT4046C
• Device Catalogue Number: VLT4046C
• Device Lot Number: VTDX0456
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CEFTRAIAXONE; CEFTRAIAXONE; GENTAMICINE; GENTAMICINE
• Outcome Attributed to Adverse Event: Other