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

Catalog Number RF048F

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided, therefore a lot history review was not performed.The sample was not returned to the manufacturer for evaluation.Medical abstract were provided and reviewed.The investigation reported issue was inconclusive for detachment.The definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model rf048f vena cava filter allegedly experienced detachment.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.

Manufacturer Narrative

H10: the reported malfunction was reassessed for reportability and determined to be reportable as a serious injury, and was reported under emdr 2020394-2021-80795.H10: g3 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 rf048f vena cava filter allegedly experienced detachment.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was 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: 10305070
• MDR Text Key: 199838180
• Report Number: 2020394-2020-04775
• 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,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: RF048F
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2021
• Type of Device Usage: A
• Patient Sequence Number: 1