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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the reported malfunction was provided and a lot history review was performed. The device was not returned for evaluation, however, medical records were provided for review. Based on that, the investigation is confirmed for perforation of the ivc and retrieval difficulties, however it is inconclusive for tilt. The definite root cause could not be determined based on the available information. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicates that model rf048f vena cava filter allegedly experienced malposition of device, patient device interaction problem and difficult to remove. This report was received from one source. One patient was involved with no reported patient injury. The (b)(6) years old female patient weight is not provided.

 
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Brand NameRECOVERY 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 Key10305068
MDR Text Key199842250
Report Number2020394-2020-04770
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 NumberRF048F
Device LOT NumberGFOG2362
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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