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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI FILTER VENA CAVA FILTER Back to Search Results
Model Number DL900J
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 one out of three malfunctions; therefore, a lot history review was performed. The samples were not returned to the manufacturer for evaluation; however, the medical records for all three malfunctions were received and reviewed. Therefore, the investigation of the reported malfunctions were confirmed for tilt. Based upon the available informations, the definitive root cause for this event is unknown. The devices were labeled for single use.

 
Event Description

This report summarizes three malfunctions. A review of the reported information indicated that model dl900j denali filter system allegedly experienced tilt. This information was received from various sources. All the three malfunctions involved patients with no patient consequences. The three patients ranged from 46-59 years of age and one patient weighed (b)(6) lbs. Of the reported patients, two were male and one was female. The remaining patients' weights are unknown.

 
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Brand NameDENALI 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 Key10302372
MDR Text Key199691887
Report Number2020394-2020-04752
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 MODEL NumberDL900J
Device Catalogue NumberDL900J
Device LOT NumberGFXL2793, 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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