MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FINESSE ULTRA BREAST BIOPSY SYSTEM; BIOPSY INSTRUMENT

Model Number	F14105US
Medical Device Problem Codes	Failure to Cycle (1142); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model f14105us biopsy instrument allegedly failed to cycle and self activated.This malfunction involved one (b)(6) year old female patient, weighing (b)(6) lbs with no reported patient injury.This information was received from one source.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model f14105us biopsy instrument allegedly failed to cycle and self activated.This malfunction involved one 63 year old female patient, weighing 220 lbs with no reported patient injury.This information was received from one source.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.For the reported malfunction, the device was returned to bd for evaluation.The evaluation was unable to identify self activation and failure to cycle as no functional tests could be performed due to the sample condition.The root cause could not be determined.The device is 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: for the reported malfunction, the device was returned to bd for evaluation.The company is still investigating the issue at this time.The device is 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 one malfunction.A review of the reported information indicated that model f14105us biopsy instrument allegedly failed to cycle and self activated.This malfunction involved one 63 year old female patient, weighing 220 lbs with no reported patient injury.This information was received from one source.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.For the reported malfunction, the device was returned to bd for evaluation.The evaluation was inconclusive for alleged cycling issue as no functional tests could be performed due to the sample condition.The root cause could not be determined.The device is 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 one malfunction.A review of the reported information indicated that model f14105us biopsy instrument allegedly failed to cycle.This malfunction involved one 63 year old female patient, weighing 220 lbs with no reported patient injury.This information was received from one source.

• Brand Name: FINESSE ULTRA BREAST BIOPSY SYSTEM
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9203090
• Report Number: 2020394-2019-04059
• Device Sequence Number: 11500819
• 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
• 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: 91007763
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 03/27/2020; 06/30/2020
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 01/07/2020; 04/01/2020; 07/10/2020
• Patient Sequence Number: 1