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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed. The return of the sample is pending. The investigation of the reported event is currently underway.
 
Event Description
It was reported that some post filter placement, the filter was found to be fractured. It was further reported that the filter was removed. There was no reported patient injury.
 
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Brand NameVENA CAVA 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 12804
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key11632584
MDR Text Key244371326
Report Number2020394-2021-00819
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN FILTER
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/08/2021 Patient Sequence Number: 1
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