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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 Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number was not provided and a lot history review could not be performed. The device was not returned for evaluation; therefore the investigation is inconclusive for detachment of device or device component, activation failure including expansion failure, and patient-device incompatibility. Based on the available information, a definitive root cause could not be determined. The device is labeled for single use. (b)(4).

 
Event Description

This report summarizes 30 malfunctions. The information reviewed indicated that model rf048f vena cava filter allegedly experienced detachment of device or device component (4), activation failure including expansion failure (12), and patient-device incompatibility (14). This information was received from one source. The malfunction involved all 30 patients with no patients¿ consequences. The age, weight, and gender were 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 Key9972954
MDR Text Key188082846
Report Number2020394-2020-02939
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 04/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberRF048F
Device LOT NumberUNKNOWN
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 Received03/31/2020
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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