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

Catalog Number MD800J

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation, however, medical records were provided.Per review of the medical records, the investigation is confirmed for difficult to remove, obstruction, detachment of device or device component, however, the investigation is inconclusive for patient device interaction problem.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model md800j vena cava filter allegedly experienced difficult to remove, obstruction, detachment of device or device component, and patient device interaction problem.This information was received from one source.This malfunction involved one patient with no consequences.The patient is (b)(6) year old male with weight (b)(6) 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
• 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: 9602185
• MDR Text Key: 177943119
• Report Number: 2020394-2020-00588
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• 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: UNKNOWN
• Date Manufacturer Received: 12/31/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1