MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ENCOR BIO PROBE 7G; BIOPSY INSTRUMENT

Catalog Number	ECP017G
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	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a vacuum assisted breast biopsy procedure using encore probe instrument.During the procedure they found a piece of plastic in the probe notch.Pieces of plastic are in the notch gap, further, concluded as contamination.There was no patient reported injury.
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 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical sample, one 7g encor biopsy probe with a complete sample trap assembly and removable probe cover were received for evaluation.Upon visual inspection, it was noted the trocar tip had blood residue.The trocar tip was examined under the microscope and particulates could be seen on the trocar tip on all sides as it was rotated.There was also a particulate on the bottom of the cutter meeting the aperture.The cutter was manually retracted to observe the sample notch.Residue could be seen within.The needle protector was examined, and skiving was noticed on the proximal entrance of the protector along with particulates on the edge of the entrance.Skiving was present near the distal end where the trocar tip meets with the needle protector when inserted (reference image).It was noticed the edges of the needle protector had irregularities along the seams.No other anomalies noted to the rear house or vacuum tubing.Lastly, small black particulates could be seen throughout the packaging of the device and concentrated where adhesive of the labels were present.No functional testing required for device contamination issue.The device was further tested.The device was received with visible blood residue on the needle and an unknown black granular material distributed throughout.The unknown material was examined and tested using hydrogen peroxide.Upon application, bubbling and foaming occurred, which is the expected reaction between dried blood and hydrogen peroxide.This confirmed that the black granular material consisted of dried blood flakes and therefore is not considered contamination.Further inspection of the probe needle and tip protector revealed skiving on the inner surface of the tip protector at the location corresponding to the trocar tip.Additional skiving was noted on the inner surface at the proximal end, where the needle is inserted and removed.Fragments of plastic from the tip protector were observed on the aperture and along the needle trocar tip, likely corresponding to the plastic material reported by the customer.The observed 'irregularities along the seams' were determined to be the gate remanent area on the outer surface of the tip protector.Post molding, the gate projection is removed manually by using a cutter.After rework, the gate area appears to be as shown.This observation is not classified as a defect because the material in the gate area has fully fused, and no holes are present.The skiving was noted on the inner surface at the proximal end and fragments of plastic from the tip protector were observed on the aperture and along the needle trocar tip.Therefore, the reported device contamination, plastic in the probe notch, can be confirmed.Potential root causes of the reported device contamination (plastic on the needle) are, but not limited to, tolerance stack-up between the needle trocar tip and plastic tip protector and user error (e.G., bend needle protector, repeated removal and replacement of tip protector).The information provided by the customer is limited and it remains unknown if the probe tip protector was removed and placed multiple times during setup and use.Therefore, the definitive root cause remains unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (medical device lot #, medical device expiration date, unique identifier (udi) #), 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a vacuum assisted breast biopsy procedure using encore probe instrument.During the procedure they found a piece of plastic in the probe notch.Pieces of plastic are in the notch gap, further, concluded as contamination.There was no patient reported injury.

• Brand Name: ENCOR BIO PROBE 7G
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city AZ 84116
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22848713
• Report Number: 2020394-2025-01309
• Device Sequence Number: 8403355
• 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): 11/25/2025

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: 07/28/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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