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
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 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
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 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.

• 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: 9869368
• Report Number: 2020394-2020-01964
• Device Sequence Number: 19552825
• 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): 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
• Operator of Device: 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 Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 06/09/2020
• 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: CEFTRIAXONE; CEFTRIAXONE; GENTAMICINE; GENTAMICINE
• Outcome Attributed to Adverse Event: Other