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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) MERIDIAN FILTER VENA CAVA FILTER

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C.R. BARD, INC. (GFO) MERIDIAN FILTER VENA CAVA FILTER Back to Search Results
Catalog Number MD800J
Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the reported malfunction was not provided, therefore a lot history review could not be performed. The device was not returned for evaluation, however medical records were provided for review. Based on the medical records, the investigation is confirmed for patient device interaction problem and malposition of the device. The definite root cause could not be determined cased on the available information. The device is labeled for single use. The catalog number identified has not been cleared in the us, but is similar to the meridian filter products that are cleared in the us. The pro code for the meridian filter products is identified. (b)(4).

 
Event Description

This report summarizes one malfunction. A review of the reported information indicates that model md800j vena cava filter allegedly experienced malposition of device and patient device incompatibility. This report was received from one source. One patient was involved with no reported patient injury. The female patient age is (b)(6) years and weight is not provided.

 
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Brand NameMERIDIAN FILTER
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
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 Key10299552
MDR Text Key199651817
Report Number2020394-2020-04684
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 07/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/20/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberMD800J
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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