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

Catalog Number MD800F

Device Problem Obstruction of Flow (2423)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided and a lot history review was performed.The device was not returned for evaluation and medical records were not provided for review, therefore the investigation is inconclusive for the reported obstruction issue.The definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the information indicates that model md800f vena cava filter allegedly experienced obstruction within device.The information was received from one source.The malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number for the reported malfunction 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 inconclusive for the reported obstruction issue.The definitive root cause is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the information indicates that model md800f vena cava filter allegedly experienced obstruction within device.The information was received from one source.The malfunction involved a patient with no reported patient injury.The female patient weight was 187 lbs and age was not provided.

• Brand Name: MERIDIAN FILTER - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9596040
• MDR Text Key: 178135250
• Report Number: 2020394-2020-00431
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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: GFWA4178
• Date Manufacturer Received: 06/30/2021
• Patient Sequence Number: 1