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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 Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Of the 2 devices, lot numbers were not provided. The lot history reviews could not be performed. Of the 2 reported malfunctions, devices were not returned for evaluation; however, medical records were provided for both malfunctions. For both malfunctions, the investigation is confirmed for migration and patient device interaction problem; however, the investigation is unconfirmed malposition of device for one malfunction. Based upon the available information, the definitive root cause is unknown. The devices were labeled for single use.

 
Event Description

This report summarizes two malfunctions. A review of the reported information indicates that model unknown filter vena cava filter allegedly experienced migration and patient device interaction problem. The information was received from various sources. Of the two malfunctions, both involved patients with no patient consequences. Two female¿s ages were reported ranging from 40 to 48; however, the weights were not reported for both patients.

 
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Brand NameNITINOL 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
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10311525
MDR Text Key199980863
Report Number2020394-2020-04968
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 07/22/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/22/2020
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
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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