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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 MD800J
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided and a lot history review was performed.The device was not returned to bd for evaluation; however, medical records were provided to review.The investigation is confirmed for occlusion of the ivc filter.Based upon the information provided, the definitive root cause is unknown.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model md800j vena cava filter allegedly experienced obstruction within device.This information was received from one source.This malfunction did involve a patient with no reported patient injury.The patient was a (b)(6) year old male that weighed (b)(6) lbs.
 
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Brand Name
MERIDIAN 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 Key9596992
MDR Text Key178117134
Report Number2020394-2020-00510
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 Other
Type of Report Initial
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberMD800J
Device Lot NumberGFXB3208
Date Manufacturer Received12/31/2019
Type of Device Usage N
Patient Sequence Number1
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