MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER; VENA CAVA FILTER

Catalog Number RF320J

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device were provided, device history reviews were performed.The samples was not returned to the manufacturer for inspection/evaluation however, medical records were provided for review.Investigation of the medical records confirmed the alleged malfunction.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model rf320j vena cava filter allegedly experienced tilt.This information was received from various sources.Of the two malfunctions, two patients were involved with no patient consequences or impacts.Of the patients involved, one was reported to be a (b)(6) female and the other was reported to be a (b)(6) the weight of both of the patients were not provided.

• Brand Name: G2 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: 10306479
• MDR Text Key: 199846089
• Report Number: 2020394-2020-04818
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RF320J
• Device Lot Number: GFSD2819; GFRF4106
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1