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

Catalog Number MD800J

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided for the reported malfunction; therefore, a lot history review could not be performed.The device was not returned for evaluation; however medical records were provided and reviewed.Therefore, the investigation is confirmed for deployment issue.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 md800j vena cava filter allegedly experienced deployment issue.The information was received from a single source.This malfunction involved one patient with no patient consequences.The female patient is (b)(6) years old.Weight of the patient was not provided.

• Brand Name: MERIDIAN FILTER SYSTEM - JUGULAR
• 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: 11703813
• MDR Text Key: 246670165
• Report Number: 2020394-2021-80374
• 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): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MD800J
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/31/2021
• Type of Device Usage: N
• Patient Sequence Number: 1