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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Event Description

This report summarizes twelve malfunctions. A review of the reported information indicated that model rf310f vena cava filter allegedly experienced tilt and perforation. This information was received from various sources. This malfunctions involved patients with no consequences. Of the twelve reported patients, the patients ranged from 37 ¿ 79 years of age and one patient was weighed (b)(6) kgs. Of the reported patients, eight were male and four were female; however, other patients weight was not provided.

 
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Brand NameG2 FILTER
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10305074
MDR Text Key199837583
Report Number2020394-2020-04772
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberRF310F
Device LOT NumberGFPK1186, GFQL0733, GFRK3958
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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