MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIO PROBE 7G; BIOPSY INSTRUMENT

Catalog Number	ECP017G
Medical Device Problem Codes	Failure to Calibrate (2440); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review the device history records have been reviewed and this lot met all release criteria.Investigation summary: one 7g encor biopsy probe was received for evaluation the device included a partial sample tray assembly and a removable probe cover the saline cap was not returned the product packaging and label were returned referencing ecp017g and lot vtjua001 the probe was received with protective tubing and appeared to be clean a visual inspection was performed including rotation of the probe body to assess for cracksnone were observed the probe gears appeared clean the aperture was received in the closed position no damage was identified to the rear housing prior to functional testing with an inhouse driver the proximal retaining cap component was examined under magnification no damage was observed on the left or right sides the returned probe was attached to two inhouse driver housings that have tighter tolerances and fit without issue the returned probe was then loaded into the inhouse driver using an inhouse saline cap and calibrated unsuccessfully during inspection of the returned probe and functional test setup it was observed that the encor probe shaft seal was detached from the mating components and the sample tray seal was found stretched no issues were found with the functional test set up or inhouse equipment due to the noted condition of the device further functional testing could not be performed dimensional evaluations of both the shaft seal and trap chamber components were conducted according to the applicable product drawings all measured dimensions were found to be within specification based on the complaint sample evaluation the reported calibration issue was confirmed additionally the investigation was confirmed for the identified detachment of device or device component a definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue a labeling review is not required.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 complainantreporter was unable or unwilling to provide any further patient product or procedural details to bd.
Event or Problem Description
It was reported that prior to a ultrasound-guided vacuum-assisted breast biopsy, the device allegedly displayed error code 1011.There was no patient contact.

• Brand Name: ENCOR BIO PROBE 7G
• 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: 23037210
• Report Number: 2020394-2025-01487
• Device Sequence Number: 15878434
• Product Code: KNW
• UDI-Device Identifier: 00801741086281
• UDI-Public: (01)00801741086281(11)240731(17)260628(10)VTJUA001
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K051158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: 06/28/2026
• Device Catalogue Number: ECP017G
• Device Lot Number: VTJUA001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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