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

Catalog Number	ECP0110G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H11: 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) 2024, a patient underwent a biopsy procedure using the encor bio probe.During the preparation of a procedure, customer received the material with the wrong label so procedure can't be done.There was no reported patient contact.
Event or Problem Description
A patient underwent a breast biopsy procedure using the encor biopsy probe.Prior to the procedure, the customer received the material with the wrong label so procedure could not be performed.There was no reported patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: although the physical sample was not returned for evaluation, one photo was provided for review.The provided photo shows the actual product labeling applied by the manufacturing facility containing all correct product information for lot vtjwd002 and product code ecp0110g.Within this provided photo, also shows the nationalization labeling that is applied by the brazil distribution center prior to release in brazil.This label contains the correct lot number vtjwd002, but the incorrect product code linked to this lot of ecp0110gv.The correct product code for lot vtjwd002 is the code on the actual product labeling sticker of ecp0110g.Therefore, the investigation is confirmed for the reported labeling problem as the national label applied by the bd brazil distribution center contained incorrect product information.No issues were noted to the labeling applied at the manufacturing facility.The root cause was determined to be a failure in the nationalization labeling process at the bd brazil distribution center, and no failure was identified with the device labeling applied at the manufacturing location.Labeling review: the encor probe label documents (baw1498100 revision 1 and baw1343900 revision 2) was reviewed.The provided photo shows the actual product labeling contains all correct product information per this document for lot vtjwd002 and product code ecp0110g.Within the same provided user photo, shows the nationalization labeling that is applied at the bd brazil distribution center prior to release in brazil.This label contains the correct lot number vtjwd002, but the incorrect product code linked to this lot of ecp0110gv.The correct product code for lot vtjwd002 is the code in the actual product labeling sticker of ecp0110g.This nationalization label is added to provide product information in the national language.The product information included on this label was incorrect and does not match the actual provided product information on the manufacturing product label.D4 (unique identifier (udi) #), g3, h6 (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 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: 22201186
• Report Number: 2020394-2025-00870
• Device Sequence Number: 20519716
• Product Code: KNW
• UDI-Device Identifier: 00801741086243
• UDI-Public: (01)00801741086243(11)241010(17)260828(10)VTJWD002
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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 Expiration Date: 08/28/2026
• Device Catalogue Number: ECP0110G
• Device Lot Number: VTJWD002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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