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

Catalog Number	ECP017GV
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
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 is currently being performed.The return of the sample is pending.However, photos were 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 underwent an ultrasound guided vacuum assisted breast biopsy with the encor probe.Torn holes were observed at the bottom of the inner package prior to the procedure.The procedure was completed with another device.There was no patient contact.
Event or Problem Description
On (b)(6) 2025, a patient getting prepared for an ultrasound guided vacuum assisted breast biopsy with the encor probe.Prior to the procedure, it was reported that the torn holes were observed at the bottom of the inner package. the procedure was completed with 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.Two electronic photos were received and reviewed.Both are identical, the photo shows the encor package with product labelling information with ecp017gv lot# vtjn0012, and expiry date 01/01/2026.Tear or rip was noted on the device packaging, and the label is not completely fixed to the plastic tray.Based on the photo review, the reported event can be confirmed.Therefore, based on the photo review, the reported tear, rip or hole in device packaging can be confirmed as tear was observed to the device packaging.The definitive root cause for the reported tear, rip or hole in device packaging could not be determined.The customer provided information is limited and remains unknown how product is received, transported or stored at the user facility.Potential causes include, but are not limited to, improper storage, rough handling, or premature unpackaging.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier udi #), g3, h6 (method, result, conclusion).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.

• 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: 22673179
• Report Number: 2020394-2025-01153
• Device Sequence Number: 20716179
• Product Code: KNW
• UDI-Device Identifier: 00801741086298
• UDI-Public: (01)00801741086298(11)241213(17)260101(10)VTJN0012
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 Expiration Date: 01/01/2026
• Device Catalogue Number: ECP017GV
• Device Lot Number: VTJN0012
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• 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