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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI JUGULAR FILTER VENA CAVA FILTER Back to Search Results
Catalog Number DL900J
Device Problems Positioning Failure (1158); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. The device has not been returned for evaluation; therefore, the investigation is inconclusive for failure to expand and failure to deploy as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based upon the available information, the definitive root cause is unknown. The device is labeled for single use.

 
Event Description

This report summarizes one (1) malfunction event. A review of the event indicated that model dl900j filter failed to expand and failed to deploy. It was reported that another filter was used to complete the procedure. This report was received from one source. The event involved a patient with no known impact to the patient. The male patient was (b)(6) years old and (b)(6) lbs.

 
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Brand NameDENALI JUGULAR 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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8279754
MDR Text Key134181607
Report Number2020394-2019-00040
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 01/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/25/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberDL900J
Device LOT NumberGFCV1527
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 Received12/31/2018
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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