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

Catalog Number	ECP0110G
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) are adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 encor probe.Prior to the procedure, it was noticed that both the external and internal packages were missing the manufacturing date.There was no patient contact.
Event or Problem Description
On (b)(6) 2025, a patient underwent a biopsy procedure using encor probe.Prior to the procedure, it was noticed that both the external and internal packages were missing the manufacturing date.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: the physical device was not returned for evaluation.No photos were provided for review.However, the investigation in unconfirmed for the reported missing information as it confirms that the date of manufacture is not included as part of the global labeling for these items.A definitive root cause for the reported missing information could not be determined based upon the provided information.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.).A definitive root cause for the reported missing information could not be determined based upon the provided information.D4 (unique identifier (udi) #), g2, g3, h4, h6 (method, result, conclusion).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.

• 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): 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: 22504543
• Report Number: 2020394-2025-01028
• Device Sequence Number: 13073188
• Product Code: KNW
• UDI-Device Identifier: 00801741086243
• UDI-Public: (01)00801741086243(11)241219(17)261101(10)VTJY0625
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K040842
• 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): 12/24/2025

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: ECP0110G
• Device Lot Number: VTJY0625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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