MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MAXCORE DISPOSABLE BIOPSY INSTRUMENT; BIOPSY INSTRUMENT

Model Number	MC2016
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the devices was provided, a manufacturing review was performed.The five samples were returned to the manufacturer for evaluation.The investigation of the reported event is confirmed for unsealed device packaging issue.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes five malfunctions.A review of the reported information indicated that model mc2016 biopsy instrument allegedly had packaging peeled open.This information was received from one source.The malfunction had no patient involvement but the patient had no consequences.The patient's age and weight was unknown.

• Brand Name: BARD MAXCORE DISPOSABLE BIOPSY INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10292586
• Report Number: 2020394-2020-04631
• Device Sequence Number: 2525894
• Product Code: KNW
• UDI-Device Identifier: 00801741084515
• UDI-Public: (01)00801741084515
• 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
• Report Date (Section B): 07/17/2020

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: MC2016
• Device Catalogue Number: MC2016
• Device Lot Number: REDY4039
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/17/2020
• Patient Sequence Number: 1