MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR MRI BIOPSY PROBE; BIOPSY INSTRUMENT

Model Number	ECPMR0110G
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two devices of the reported malfunctions have been returned to the manufacturer for evaluation.The investigation of the two returned devices is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model ecpmr0110g biopsy instrument allegedly had a foreign material present in the device.This information was received from various sources.None of the two malfunctions involved a patient.The age, weight, and gender of the intended patients was not provided.
Additional Manufacturer Narrative
H10: two lot numbers have been provided and lot history reviews will be performed.Two devices of the reported malfunctions have been returned for evaluation and foreign material was not identified for either device.The definitive root cause could not be established.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 two malfunctions.A review of the reported information indicated that model ecpmr0110g biopsy instrument allegedly had a foreign material present in the device.This information was received from various sources.None of the two malfunctions involved a patient.The age, weight, and gender of the intended patients was not provided.

• Brand Name: ENCOR MRI BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9211458
• Report Number: 2020394-2019-04107
• Device Sequence Number: 3396355
• Product Code: KNW
• UDI-Device Identifier: 00801741086304
• UDI-Public: (01)00801741086304
• 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: ECPMR0110G
• Device Catalogue Number: ECPMR0110G
• Device Lot Number: VTDN0042, VTCW0468
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1