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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) DENALI FILTER VENA CAVA FILTER

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C.R. BARD, INC. (GFO) DENALI FILTER VENA CAVA FILTER Back to Search Results
Model Number DL900J
Device Problems 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 three malfunctions were not provided, therefore a lot history review could not be performed. All three malfunctions devices were not returned for evaluation, however medical record were provided for review. Two of three malfunctions were confirmed for filter tilt and perforation of the inferior vena cava filter. The definite root cause could not be determined based on the available information. The company is still investigating the issue at this time for one malfunction. The device is labeled for single use.

 
Event Description

This report summarizes three malfunctions. A review of the reported information indicated that model dl900j vena cava filter allegedly experienced malposition of device and patient device interaction problem. The information was received from various sources. All three malfunctions involved patients with no reported patient injury. The three patients ranged from 47-77 years of age and weight is not provided. Of the reported patients, two were male and one gender was not provided.

 
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Brand NameDENALI FILTER
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
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 Key10314041
MDR Text Key200054346
Report Number2020394-2020-05000
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 MODEL NumberDL900J
Device Catalogue NumberDL900J
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 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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