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

Model Number	MN1616
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model mn1616 biopsy instrument experienced needle rust.This information was received from one source.This malfunction involved one patient with no patient consequences.The (b)(6) year old female patient was (b)(6) kgs.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction 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.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 reported information indicated that model mn1616 biopsy instrument experienced needle rust.This information was received from one source.This malfunction involved one patient with no patient consequences.The 68 year old female patient was 53 kgs.

• Brand Name: MAGNUM NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10280207
• Report Number: 2020394-2020-04468
• Device Sequence Number: 14085029
• Product Code: FCG
• UDI-Device Identifier: 00801741084300
• UDI-Public: (01)00801741084300
• 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): 10/19/2020

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: MN1616
• Device Catalogue Number: MN1616
• Device Lot Number: REBU1002
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/19/2020
• Patient Sequence Number: 1