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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 Problems Activation, Positioning or SeparationProblem (2906); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

For the reported malfunction, a lot number was provided, and lot history review was performed. The device was not returned to bd for evaluation, but an image was provided for review. The company is still investigating the issue at this time. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicated that model dl900j vena cava filter allegedly experienced a deployment issue. This information was received from one source. The malfunction involved a patient with no known impact to the patient. The patient was a (b)(6) year old female; weight was not provided.

 
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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 Key9590852
MDR Text Key179310172
Report Number2020394-2020-00267
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,Followup,Followup
Report Date 07/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2020
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 NumberGFDX0637
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
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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