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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 Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number was provided for one malfunction and a lot history review was performed. The devices were not returned for both malfunctions. Medical records were provided for one malfunctions. For both malfunction, the investigation is inconclusive for filter limb detachment. Based upon the available information, the definitive root cause for this event is unknown. The device is labeled for single use.

 
Event Description

This report summarizes two malfunctions. A review of the reported information indicates that model rf310f vena cava filter allegedly experienced detachment of device or device component. The information was received from various source. Of the two malfunctions, both involved patients with no patient consequences. Of the two reported malfunctions one patient was female and other patient was male. Age and weight not provided for both patients.

 
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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 Key10314931
MDR Text Key200209146
Report Number2020394-2020-05005
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 07/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberRF310F
Device LOT NumberGFQF4284, UNKNOWN
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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