MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FINESSE ULTRA 14G PROBE; BIOPSY INSTRUMENT

Model Number	F14105US
Medical Device Problem Codes	Failure to Cycle (1142); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the 2 reported event, 1 lot number was provided, and lot history review.Of the 2 reported event, 1 sample was not returned, therefore, investigation for the sample not returned is inconclusive.One sample was returned for evaluation.Failure to cycle and difficult to remove was not identify for the device.Therefore, the investigation of the reported event is inconclusive.A root cause has not been determined.The device was labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model f14105us.Biopsy instrument allegedly failure to cycle and difficult to remove.These reports were received from various sources.All two events had no reported patient injury.Both patient age range from 36-55 years old, weight range from 125-145 lbs, and both patients were female.

• Brand Name: FINESSE ULTRA 14G PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9204206
• Report Number: 2020394-2019-04068
• Device Sequence Number: 3031450
• Product Code: KNW
• UDI-Device Identifier: 00801741085161
• UDI-Public: (01)00801741085161
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: F14105US
• Device Catalogue Number: F14105US
• Device Lot Number: UNKNOWN, 91008013
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1