MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIO PROBE 12G VERT; BIOPSY INSTRUMENT

Catalog Number	ECP0112GV
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a biopsy procedure using the encor bio probe.Prior to the procedure, it was observed that a piece of rubber was present in the notch, which made it unusable.There was no patient contact.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, photo was provided for review.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 a biopsy procedure using the encor bio probe.Prior to the procedure, it was observed that a piece of rubber was present in the notch, which made it unusable.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 electronic photo was provided and reviewed.The photo shows the distal end of one encor probe needle.The probe body, trap chamber subassemblies, and the product packaging were not visible in the photo.The probe cutter is shown in the fully closed position.Upon zooming in to 50 percentage, a substance is observed on the probe cutter.No additional anomalies are noted to the probe needle or trocar tip.Based on the complaint sample evaluation and photo review, the reported device contamination (rubber like substance/debris in the probe notch) is unconfirmed and the identified device contamination (plastic material) was confirmed.The materials observed on the received probe were determined to consist of saline residue, silicone oil, and plastic debris from the tip protector.One 12gv encor biopsy probe with a partial sample trap assembly and a removable probe cover were received for evaluation.The saline cap was not returned.Product packaging and label were returned for the encor biopsy probe.The probe was received with protective tubing.The encor biopsy probe appeared to have saline throughout the saline tubing and sample trap assembly.The probe body was rotated to identify any cracks.No cracks were observed on the probe body.The probe gears appeared to be clean.It was observed that the aperture was received closed.Apparent blood residue was observed to the needle.During inspection of the returned device, a substance was observed on the probe aperture.Apparent plastic material was noted around the trocar tip.Skiving was observed on the inner proximal surface of the tip protector, and the tip protector was missing from cavity 1.Visual inspection of the returned probe and rear housing did not identify any damage.Dried saline residue was noted inside the packaging and within the tissue chamber.Moisture droplets and residue were observed on the needle aperture.When the aperture was manually opened to approximately halfway, similar moisture droplets were observed internally.The needle protector exhibited a crack and skiving at the proximal end near the opening.No additional anomalies were identified.According to information provided by the customer, transparent rubber like debris was observed near the probe notch.The substance was reportedly noticed upon opening the packaging and removing the needle for use.The customer indicated that there were no observed deficiencies with the product packaging.The plastic material observed was identified as originating from the needle protector.Plastic debris noted on the cutter surface, specifically in the helical tip area, is consistent with debris generated from the protective tube (needle protector).This type of debris may occur during insertion or removal of the needle protector.The root cause of the silicone oil observed at the probe notch was attributed to the manufacturing assembly process; however, its presence was determined to be acceptable.The root cause of the plastic debris from the tip protector could not be determined.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D1, d4 (medical device catalog #, medical device lot #, medical device expiration date, unique identifier (udi) #), g1(manufacturing location), g3, h6 (component, method, result, conclusion).Section a through f: the information provided 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 12G VERT
• 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: 23308455
• Report Number: 2020394-2025-01690
• Device Sequence Number: 5788640
• Product Code: KNW
• UDI-Device Identifier: 00801741086274
• UDI-Public: (01)00801741086274(11)240207(17)260528(10)VTJTJ001
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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): 03/23/2026

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 Expiration Date: 05/28/2026
• Device Catalogue Number: ECP0112GV
• Device Lot Number: VTJTJ001
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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