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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 Problem Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number was provided for two out of five malfunctions, therefore, a lot history reviews were performed. The devices were not returned for evaluation; however medical records were provided for four malfunctions. Two malfunctions confirmed for tilt and two were inconclusive for tilt. For the remaining malfunction, the investigation is inconclusive as no objective evidence was provided for review. Based on the available information, the definitive root cause is unknown. The devices are labeled for single use.

 
Event Description

This report summarizes five malfunctions. A review of the reported information indicates that model rf310f vena cava filter allegedly tilted. These reports were received from various sources. Of the five reported malfunctions, four were male and three patients age ranged from 44 to 52 years old. The remaining patient's age, weight, and gender 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 Key10305462
MDR Text Key199840656
Report Number2020394-2020-04787
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
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 NumberGFPG2595,UNKNOWN,GFQA2791
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
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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