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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SNF/SL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. SNF/SL VENA CAVA FILTER Back to Search Results
Model Number 2120F
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review was performed. The sample was not returned to the manufacturer for inspection/evaluation; however, medical records were provided for review. The investigation is inconclusive for filter migration. A definitive root cause for the reported event could not be determined. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicated that model 2120f vena cava filter allegedly experienced migration of device or device component. This information was received from one source. The event involved a patient with no known impact to the patient. The age and weight of male patient was not provided.

 
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Brand NameSNF/SL
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 Key10273975
MDR Text Key198853757
Report Number2020394-2020-04441
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 07/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number2120F
Device Catalogue Number2120F
Device LOT NumberGFRD1207
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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