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

Model Number	ECP0112G
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
Event or Problem Description
This report summarizes 27 malfunctions.The information reviewed indicated that model ecp0112g allegedly experienced foreign material present in the device.This information was received from various sources.All of the reported malfunctions did not involve a patient as there was no patient contact.Age, weight, and gender were not reported for any of the patients.
Additional Manufacturer Narrative
H10: out of the 27 reported malfunctions, 5 lot numbers were provided and a lot history review will be performed.For the 27 reported malfunctions, 27 devices were returned for evaluation.Foreign material was confirmed in 13 of the devices and foreign material was identified in 14 devices.The definitive root cause for the reported event is unknown.The devices were labeled for single use.H10: d4(lot number: vtds0312, vtdt0406).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 27 malfunctions.The information reviewed indicated that model ecp0112g allegedly experienced foreign material present in the device.This information was received from various sources.All of the reported malfunctions did not involve a patient as there was no patient contact.Age, weight, and gender were not reported for any of the patients.

• Brand Name: ENCOR BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9588537
• Report Number: 2020394-2020-00242
• Device Sequence Number: 14371107
• Product Code: KNW
• UDI-Device Identifier: 00801741086267
• UDI-Public: (01)00801741086267
• 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): 04/02/2020

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: ECP0112G
• Device Catalogue Number: ECP0112G
• Device Lot Number: VTDP0097, VTDN0043, VTDR0249
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1