MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

Model Number	121410
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation.The company is investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the information indicated that model 121410 biopsy instrument allegedly self-activated.This information came from one source.No patient was involved and no patient information was provided.
Additional Manufacturer Narrative
H10.For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.Self-activation was undefined for the device.A root cause has not been determined.The device was 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 information indicated that model 121410 biopsy instrument allegedly self-activated.This information came from one source.No patient was involved and no patient information was provided.

• Brand Name: BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9239890
• Report Number: 2020394-2019-04322
• Device Sequence Number: 18865288
• Product Code: KNW
• UDI-Device Identifier: 00801741084584
• UDI-Public: (01)00801741084584
• 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): 01/08/2020

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: 121410
• Device Catalogue Number: 121410
• Device Lot Number: RECU1789
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1