MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIO PROBE 7G; BIOPSY INSTRUMENT

Catalog Number	ECP017G
Medical Device Problem Codes	Nonstandard Device (1420); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent vacuum assisted breast biopsy procedure using the encor biopsy system with the encor biopsy probe.Prior to port placement procedure, package allegedly contains oily substance in the probe notch.There was no patient contact.
Additional Manufacturer Narrative
H11: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Section a through f: the information provide by bd represents all 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
On (b)(6) 2025, a patient underwent vacuum assisted breast biopsy procedure using the encor biopsy system with the encor biopsy probe.Prior to port placement procedure, package allegedly contains oily substance in the probe notch.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one 7g encor biopsy probe with a complete sample trap assembly, removable probe cover was received for evaluation.The syringe adapter and additional sample tray were also returned with the complaint sample.Product packaging and label were returned and verified with tw.The probe was received with protective tubing.The encor biopsy probe appeared to be clean.The probe body was rotated to identify any cracks.No cracks were observed on the probe body.The probe gears appeared to be clean and the aperture was received closed.Upon visual inspection, no damage was identified to the returned probe or the rear housing.Under microscopic examination a substance was noted throughout the probe aperture.No other anomalies noted.One electronic photo was provided and reviewed.The photo shows the distal end of one encor probe needle.The probe body and trap chamber subassemblies were not visible in the photo.The product packaging tray can be seen in the background, however the tyvek lid and product label are not visible.The probe cutter is shown in the fully closed position.Upon zooming in to 50%, a substance is observed on the probe cutter.No additional anomalies are noted to the probe needle or trocar tip.A manufacturing review was conducted to assess the potential source of the observed substance.Based on this review, the substance was identified as silicone oil applied to the cannula and cutter components during the manufacturing assembly process.The amount of silicone present on the probe cutter was determined to be excessive (overflow).Therefore, based on the photo review and complaint sample evaluation, the reported device contamination (substance on probe notch) is unconfirmed and the investigation is confirmed for the identified nonstandard device issue (overflow of silicone).The root cause was determined to be manufacturing-related.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, d4 (unique identifier (udi) #), g3, h6 (device, component, method, result, conclusion).Section a through f: the information provide by bd represents all 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.

• Brand Name: ENCOR BIO PROBE 7G
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): AUSA MEDICAL DEVICES PVT LTD; 15b bommasandra indl area; hosur road, attibele hobli; anekal taluk, bangalore 560 9 99; IN 560 999
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22455753
• Report Number: 2020394-2025-00999
• Device Sequence Number: 8156129
• Product Code: KNW
• UDI-Device Identifier: 00801741086281
• UDI-Public: (01)00801741086281(11)241227(17)261128(10)VTJZA001
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K051158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: Health Professional
• Device Catalogue Number: ECP017G
• Device Lot Number: VTJZA001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown