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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SNF/SL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. SNF/SL VENA CAVA FILTER Back to Search Results
Model Number 2220J
Device Problem Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The lot no for the device was provided, therefore a lot history review was performed. The device was not returned for evaluation. Medical records were provided and reviewed. Therefore, the investigation is confirmed for perforation. Based on the available information, the definitive root cause is unknown. The device is labeled for single use.
 
Event Description
A review of the reported information indicated that model 2220j vena cava filter experienced perforation. The information was received from a one source. This malfunction involved one patient with no patient consequences. The female patient is (b)(6). Weight of the patient was not provided.
 
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Brand NameSNF/SL
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 Key12191593
MDR Text Key262488578
Report Number2020394-2021-80583
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
Type of Report Initial
Report Date 07/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2220J
Device Catalogue Number2220J
Device Lot NumberGFRI4715
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 Received06/30/2021
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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