VENAFLO VASCULAR GRAFT V4007C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-29 for VENAFLO VASCULAR GRAFT V4007C manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[176972759] The lot number for the device was provided. The device history records are currently under review. The return of the device is pending. The results of the anticipated device evaluation will be provided upon completion of the event investigation. The information provided by bd 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 bd.
Patient Sequence No: 1, Text Type: N, H10


[176972760] It was reported that some time post graft placement the patient experienced thrombosis of an avf brachia-cephalic at the elbow. It was further reported that the physician performed a partial excision and interpolate the graft at the arterial puncture site. Reportedly, the patient experienced an infection some time post placement and was treated with an iv injection. After the iv injection the patient experienced a reaction at the puncture site. The health care provider decided to remove the graft from the patient. Patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2020-00830
MDR Report Key9644805
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-29
Date of Report2020-03-23
Date of Event2019-12-29
Date Mfgr Received2020-03-20
Device Manufacturer Date2018-07-18
Date Added to Maude2020-01-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJUDITH LUDWIG
Manufacturer Street1415 W. 3RD STREET
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1BARD PERIPHERAL VASCULAR, INC.
Manufacturer Street1625 W 3RD ST.
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal Code85281
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENAFLO VASCULAR GRAFT
Generic NameVASCULAR GRAFT
Product CodeDSY
Date Received2020-01-29
Catalog NumberV4007C
Lot NumberVTCU0303
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 W 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-01-29

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.