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

Model Number	2120F
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.However, medical record was received for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
A review of the reported information indicates that model 2120f vena cava filter allegedly experienced migration, positioning issue and failure to expand.The information was received from a single source.This malfunction involved one patient with no patient consequences.A (b)(6) years old female patient weighs (b)(6) kgs.
Event or Problem Description
A review of the reported information indicates that model 2120f vena cava filter allegedly experienced migration, positioning issue and failure to expand.The information was received from a single source.This malfunction involved one patient with no patient consequences.A 61 years old female patient weighs 104 kgs.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction was not provided, therefore, a lot history review could not be performed.The device was not returned for evaluation.Medical records were provided and reviewed.Therefore, the investigation is confirmed for migration, positioning issue and failure to expand.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.H10: g3, h6(method).H11: h6(result, conclusion).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.

• Brand Name: SIMON NITINOL FILTER
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11703819
• Report Number: 2020394-2021-80373
• Device Sequence Number: 17120746
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 07/08/2021
• Patient Sequence Number: 1