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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER VENA CAVA FILTER Back to Search Results
Catalog Number MD800F
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Of the 4 devices, 4 lot numbers were provided and the lot history reviews were performed. Of the 4 reported malfunctions, devices were not returned for evaluation; however, medical records were provided for all malfunctions. For one malfunction, the investigation is inconclusive for malposition of device and patient device interaction problem. For the remaining three malfunctions, the investigation is confirmed for patient device interaction problem; however, investigation is inconclusive for malposition of device. Based upon the available information, the definitive root cause is unknown. The devices were labeled for single use. (corporate lot no: gfxf3667).

 
Event Description

This report summarizes four malfunctions. A review of the reported information indicates that model md800f vena cava filter allegedly experienced malposition of device and patient device interaction problem. The information was received from various sources. All the four malfunctions involved patients with no patient consequences. Of the four malfunctions, three were female and one was male. Of the four malfunctions, three patient's ages were reported ranging from 42 to 64. The weight of the one patient was (b)(6) lbs. No other patient information was provided.

 
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Brand NameMERIDIAN 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 Key10304123
MDR Text Key199836859
Report Number2020394-2020-04765
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 07/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberMD800F
Device LOT NumberGFWA4163, GFXH2774, GFWH2370
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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