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
Of the two reported malfunctions, one lot number was provided and a lot history review will be performed.The second lot number is unknown.One sample has been returned for evaluation.The company is still investigating the issue at this time.The second investigation is inconclusive as no sample was returned for evaluation.The devices were labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of reported information indicates that model f14105us, biopsy instrument, allegedly experienced failure to cycle and removal difficulty.This information was received from multiple sources.These malfunctions both involved patients.One patient was reported as female, weight and age were not provided.No information was available for the second patient.
Additional Manufacturer Narrative
H10: of the two reported malfunctions, one lot number was provided and a lot history review was performed.The second lot number was unknown.One sample has been returned for evaluation and the investigation was confirmed for failure to disconnect and inconclusive for failure to cycle and difficult to remove due to the returned sample condition.The definitive root cause could not be determined based upon the available information.The second investigation was inconclusive as no sample was returned for evaluation.The devices were labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of reported information indicates that model f14105us, biopsy instrument allegedly experienced failure to cycle and removal difficulty.This information was recieved from multiple sources.Of the two malfunctions, both involved patients with no patient consequences.One patient was reported as female.Weight and age for both patients were not provided.

• 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: 9959086
• Report Number: 2020394-2020-02665
• Device Sequence Number: 11371955
• 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,Followup
• Report Date (Section B): 07/10/2020

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: 91008083, UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/28/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 07/10/2020
• Patient Sequence Number: 1