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

Catalog Number	ECP017GV
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
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
It was reported that prior to a vacuum-assisted breast biopsy procedure, the probes outer packaging was allegedly damaged.It was further reported that the inner package was damaged.Reportedly, there was a breach in the sterile packaging.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records were reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation however, three electronic photos were provided and reviewed.The first photo shows packaged encor probe laying on a flat surface.A portion of the encor probe trap chamber and tubing is visible within the package, but the probe body and needle are not visible.A crack is visible and noted to the packaging tray and a sheet of paper was used to highlight the crack on the packaging tray.No other anomalies were noted.The second photo shows the same probe laying on a flat surface with the clear packaging tray facing up.The packaging appears to be sealed and the encor probe is visible within the package.No anomalies were noted.The third photo shows the same packaged encor probe laying on a flat surface with the opposite side facing up.The product label is visible reflecting ecp017gv, lot# vtjn0013 and expiration 2026-01-01.No anomalies were noted to the tyvek or product label.Therefore, based on the photo review, the reported tear, rip or hole in device packaging can be confirmed as cracks were observed to the device packaging.The reported outer packaging problem remains inconclusive as the provided photos did not provide images of the allegedly damaged outer package.The definitive root cause for the reported tear, rip or hole in device packaging could not be determined.The potential root causes include, but are not limited to, insufficient packaging or incorrect packaging/repackaging orientation of the device.The definitive root cause for the reported outer packaging problem could not be determined.The potential root causes include, but are not limited to, incorrect packaging orientation, insufficient packaging material, mishandling, transit damage, storage issues, etc.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 complainant/reporter 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 vacuum-assisted breast biopsy procedure, the probes outer packaging was allegedly damaged.It was further reported that the inner package was damaged.Reportedly, there was a breach in the sterile packaging.The procedure was completed using another device.There was no patient contact.

• Brand Name: ENCOR BIO PROBE 7G VERT
• 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: 21838215
• Report Number: 2020394-2025-00564
• Device Sequence Number: 18133570
• Product Code: KNW
• UDI-Device Identifier: 00801741086298
• UDI-Public: (01)00801741086298(11)240213(17)260101(10)VTJN0013
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 06/16/2025

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: 01/01/2026
• Device Catalogue Number: ECP017GV
• Device Lot Number: VTJN0013
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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