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
For both of the complaints, 1 device product catalog and lot number was unknown, a manufacturing review could not be performed.Of the 2 reported malfunctions, 1 device lot number was provided, and lot history review.The sample were returned for evaluation.A backward bent was identified for both devices.A root cause has not been determined.The device was labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 121410.Biopsy instrument allegedly self activated.The procedure was completed using another device.These reports were received from various sources.Both events did not involve patients.One patient is female; however, all other patients age, weight, gender was not provided.
Additional Manufacturer Narrative
There were originally two reported malfunctions for product catalog number 121410.Of the two devices, the product catalog number of one device was updated to (b)(4).The lot number for the two malfunctions were provided and a lot history review was performed.The two devices have been returned for evaluation; the evaluation of one device with catalog number 121410 could not reproduce the malfunction.The evaluation for the one device with catalog number 121820 was inconclusive.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 121410 biopsy instrument allegedly self-activated.This information was received from one source.The event did not involve a patient and therefore had no patient consequence.The patient is female, but weight and age were not 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: 8812359
• Report Number: 2020394-2019-01663
• Device Sequence Number: 14239758
• 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): 10/09/2019

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: REDP0089
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1