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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. NITINOL FILTER; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. NITINOL FILTER; VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for evaluation; however, medical records were provided for review.The investigation is confirmed for occlusion of the inferior vena cava filter.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
 
Event Description
A review of the reported information indicated that model unknown vena cava filter allegedly experienced obstruction of flow.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) old female patient weight was not provided.
 
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Brand Name
NITINOL FILTER
Type of Device
VENA 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 Key12197228
MDR Text Key262474395
Report Number2020394-2021-80610
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNKNOWN FILTER
Device Lot NumberUNKNOWN
Date Manufacturer Received06/30/2021
Type of Device Usage N
Patient Sequence Number1
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