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

Model Number	MC2016
Medical Device Problem Codes	Failure to Prime (1492); Self-Activation or Keying (1557); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot no for the device was provided, therefore a lot history review was 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.(device: 2981).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model mc2016 biopsy instrument experienced failure to prime, failure to obtain samples, self activation and needle bent.This report was received from one source.This malfunction involved one patient with no patient consequences.Age, weight, and gender were not provided.

• Brand Name: MAXCORE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10731266
• Report Number: 2020394-2020-06033
• Device Sequence Number: 14230922
• 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): 10/23/2020

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: REDQ4102
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/23/2020
• Patient Sequence Number: 1