MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. EnCor Probe; Biopsy Instrument

Catalog Number	ECP0112GV
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient prepped for a vacuum assisted breast biopsy procedure using encore probe instrument.Prior to the procedure, it was noticed that labelling information were missing.There was no patient contact.
Additional Manufacturer Narrative
H11: 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.However, a photo was provided for review.The investigation of the reported event is currently underway.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 was scheduled to undergo a vacuum-assisted breast biopsy procedure using an encor probe instrument.Prior to the procedure, during a stock inspection, it was noted that the device labeling information was missing.The device was not used, and there was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the reported lot number was unknown, therefore a device history record (dhr) review was not initially requested.Investigation summary: the physical device was not returned for evaluation.One electronic photo was provided by the customer and reviewed.The image showed two sealed encor probe packages positioned side-by-side, with one package displaying the product label and the second package appearing to have no label affixed to the tyvek lid and no apparent residual adhesive or indications of prior label placement was present on the tyvek.According to the limited information provided by the customer, they alleged no label on the probe was suspected from batch vtjtj001, but could not be sure since it was already removed from the box.Based on the photo review and customer allegation, the investigation is confirmed as no product label was affixed to the tyvek lid and no evidence or adhesive or prior label placement was observed.A sales history review determined products shipped to mount elizabeth novena hospital (mnh) were specific to adroit lots.As distribution records indicate shipment of adroit manufactured probe lots and the customer suspected lot vtjtj001, a manufacturing process review, including dhr review for suspected lot vtjtj001 was performed.The review identified no manufacturing discrepancies, no documented instances of product packages progressing through the manufacturing process without labels applied, and no instances in which missing labels were identified prior to final release.The lot met all release criteria.Based on the available evidence, the investigation determined the missing label condition was attributed to the manufacturing process, as no adhesive residue or other evidence was observed to indicate that a label had previously been applied and later removed.Labeling review: a review of label, tyvek lid, encor probe, global (baw1498200, rev.1) determined the product labeling documentation is adequate.This document verifies the date of manufacture is not part of the global labeling of the items.A review of label, carton, encor probe, global (baw1498100, rev.1) determined the product labeling documentation is adequate.This document verifies the date of manufacture is not part of the global labeling of the items.B5, d4 (unique identifier (udi) #), g1, g3, h6 (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 Probe
• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 23653534
• Report Number: 2020394-2025-01951
• Device Sequence Number: 18672844
• Product Code: KNW
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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