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
Additional Manufacturer Narrative
The lot number for this sole complaint was not provided.Therefore, a lot history review cannot be performed.The device was returned for evaluation.The company is still investigating the issue at this time.The devices are labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that a ecp0112g biopsy instrument allegedly experience foreign material inside the packaging.This report was received from one source.Age, weight, and gender were not provided for the patient.There was no reported patient contact.
Additional Manufacturer Narrative
H10: one device was returned for the reported malfunction.As the lot number was provided, a lot history review will be performed.The device evaluation identified device contamination with chemical or other material.A root cause could not be determined.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.The information reviewed indicated that a ecp0112g biopsy instrument allegedly experienced device contamination with chemical or other material.This report was received from one source.Age, weight, and gender were not provided for the patient.There was no reported patient contact.

• 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: 9211565
• Report Number: 2020394-2019-04112
• Device Sequence Number: 305855
• 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): 01/07/2020

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: VTDN0043
• 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: 01/07/2020
• Patient Sequence Number: 1