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

Catalog Number MD800J

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review will be performed.The sample was not returned to the manufacturer for evaluation; however, medical records were provided for review.The company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model md800j vena cava filter allegedly experienced malposition of device and detachment of device or device component.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old female patient is (b)(6) kgs.

Manufacturer Narrative

H10: as the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation; however, medical records were provided for review.Therefore, the investigation is confirmed for the reported malposition of device and detachment of device or device component.Based upon the available information, the definitive root cause for this event 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 reported information indicated that model md800j vena cava filter allegedly experienced malposition of device and detachment of device or device component.This information was received from one source.The malfunction involved a patient with no known impact to the patient.A 51 years old female patient weighs 90 kgs.

• 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: 10757220
• MDR Text Key: 213871641
• Report Number: 2020394-2020-06294
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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: GFXC3743
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1