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); Separation Failure (2547); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The samples were not returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model f14105us biopsy instrument allegedly failed to cycle, was difficult to remove, and failed to separate.There was no reported patient injury.The female patients age ranged from (b)(6) years to (b)(6) years.This information was received from one source.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model f14105us biopsy instrument allegedly failed to cycle, was difficult to remove, and failed to separate.There was no reported patient injury.The female patients age ranged from 42 years to 53 years.This information was received from one source.
Additional Manufacturer Narrative
H10: the three samples were returned for evaluation.The company is still investigation the issue at this time.The devices were labeled for single use.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 or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model f14105us biopsy instrument allegedly failed to cycle, was difficult to remove, and failed to separate.This information was received from one source.Both reported malfunctions involved patient with no consequences.The female patients age ranged from 42 years to 53 years.
Additional Manufacturer Narrative
H10: of the three reported malfunctions two devices were returned for evaluation.As the lot number was provided, a lot history review will be performed.For one of the malfunctions, the investigation identified failure to cycle and failure to separate.A root cause could not be determined.The company is still investigating the other malfunction at this time.The devices were labeled for single use.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.
Additional Manufacturer Narrative
H10: of the three reported malfunctions two devices were returned for evaluation.As the lot number was provided, a lot history review will be performed.For one of the malfunctions, the investigation identified failure to cycle and failure to separate, however did not identify difficulty to remove.For the other malfunction, difficulty to remove, failure to cycle, and failure to separate could not be identified.A root cause could not be determined.The devices were labeled for single use.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 or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model f14105us biopsy instrument allegedly failed to cycle, was difficult to remove, and failed to separate.This information was received from one source.Both reported malfunctions involved patient with no consequences.The female patients age ranged from 42 years to 53 years.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model f14105us biopsy instrument allegedly failed to cycle, was difficult to remove, and failed to separate.This information was received from one source.Both reported malfunctions involved patient with no consequences.The female patients age ranged from 42 years to 53 years.
Additional Manufacturer Narrative
H10: of the three reported malfunctions two devices were returned for evaluation.As the lot number was provided, a lot history review will be performed.All 3 malfunctions were reassessed and determined to have experience device-device incompatibility instead of failure to separate.For one of the malfunctions, the investigation is unconfirmed for failure to cycle, difficult to remove, and device-device incompatibility.For one malfunction, the investigation is inconclusive for failure to cycle, difficult to remove, and device-device incompatibility.For another malfunction, the investigation is inconclusive as the device was not returned for evaluation.The definitive root cause could not be determined.The devices were labeled for single use.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: 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: 8813635
• Report Number: 2020394-2019-01709
• Device Sequence Number: 16784965
• 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,Followup,Followup,Followup
• Report Date (Section B): 07/14/2020

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: 91007920
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 12/31/2019; 03/31/2020; 06/29/2020
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/11/2019; 01/06/2020; 04/02/2020; 07/14/2020
• Patient Sequence Number: 1