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

Catalog Number RF048F

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

The lot number was provided for one malfunction out of two malfunctions, therefore a lot history review was performed.The samples were not returned for evaluation but medical records were provided for both malfunctions.The investigation is confirmed for filter limb detachment and tilt for both malfunctions.The definitive root cause could not be determined based upon available information.The devices were labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model rf048f vena cava filter allegedly experienced tilt and detachment.This information was received from various sources.This malfunction involved two patients with no consequences.One patient is a (b)(6) year old female and the other is a (b)(6) year old female.Both of the patients' weights were not provided.

• Brand Name: RECOVERY 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: 10757392
• MDR Text Key: 213869337
• Report Number: 2020394-2020-06300
• 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: 10/29/2020

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: RF048F
• Device Lot Number: GFOG1387, UNKNOWN
• Date Manufacturer Received: 09/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1