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

Catalog Number MD800F

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device for this malfunction has not been returned to the manufacturer for evaluation, however, medical records and an x-ray image have been provided.The investigation of the reported malfunction is currently underway.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model md800f vena cava filter allegedly migrated and had a positioning issue.This information was received from one source.One patient was involved with no patient consequence.The (b)(6) male patient¿s weight was not provided.

Manufacturer Narrative

H10: the device for this malfunction has not been returned to the manufacturer for evaluation, however, medical records and an x-ray image have been provided.The investigation is confirmed for the alleged positioning issue, however, it is inconclusive for the alleged migration.Based upon the available information, the definitive root cause is unknown.The device was labeled for single use.H10: g4 h11: b5, h6 (results, conclusion) 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 reported information indicated that model md800f vena cava filter allegedly migrated and experienced a positioning issue.This information was received from one source.One 76 year old male patient was involved with no patient consequence.The patient's 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
• MDR Report Key: 9216374
• MDR Text Key: 163128163
• Report Number: 2020394-2019-04219
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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: GFWL2919
• Date Manufacturer Received: 12/31/2019
• Patient Sequence Number: 1