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
As the lot number for the device was not provided, a manufacturing review will not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the event indicated that model f14105us biopsy instrument experienced during a breast biopsy, the device allegedly failed to cycle and difficult to remove.It was further reported that the procedure was completed with another device and no coaxial was used.The report was received from one source.This event involved one patient with no reported patient injury.Patient was a (b)(6) year old female, weighing (b)(6) kgs.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a manufacturing review will not be performed.The sample was returned to bd for evaluation.The investigation of the reported malfunction is currently underway.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 event indicated that model f14105us biopsy instrument allegedly experienced failure to cycle and difficult to remove.It was further reported that the procedure was completed with another device and no coaxial was used.The report was received from one source.This malfunction involved one patient with no reported patient injury.Patient was a 36 year old female, weighing 66 kgs.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model f14105us biopsy instrument allegedly experienced failure to cycle and difficult to remove.The report was received from one source.This malfunction involved one patient with no reported patient injury.The patient was a 36 year old female, weighing 66 kgs.
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review will not be performed.The sample was returned to bd for evaluation.The device evaluation could not be performed due to the sample condition, therefore, the investigation is inconclusive for failure to cycle and difficult to remove as no objective evidence has been provided to confirm any alleged deficiency with the device.The definitive root cause could not be determined.The device is labeled for single use.(mdr contact office), h6 (results, 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: 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: 8807973
• Report Number: 2020394-2019-01613
• Device Sequence Number: 457405
• 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
• Report Date (Section B): 01/16/2020

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: UNKNOWN
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 12/31/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 10/22/2019; 01/16/2020
• Patient Sequence Number: 1