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

Catalog Number MD800F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); 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 provided, therefore, a lot history review was performed.The device was not returned to the manufacturer for evaluation; however, medical records are provided and reviewed.Therefore, the investigation is confirmed for detachment, filter tilt, limbs detachment and perforation.The definitive root cause could not be determined based upon available information.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates the model md800f vena cava filter allegedly experienced tilt, detachment and filter perforation.The report was received from a single source.This malfunction involved patient with no known impact to the patient.The female patient age is (b)(6) years old and weight was not provided.

• 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 Key: 10756864
• MDR Text Key: 213873714
• Report Number: 2020394-2020-06280
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MD800F
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1