MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ELEVATION BREAST BIOPSY SYSTEM DRIVER; BIOPSY INSTRUMENT

Catalog Number	EVDRIVER
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 the elevation device sticker is illegible as the sticker has worn off.
Additional Manufacturer Narrative
H11: manufacturing review: a dhr and manufacturing review was not required as the event was determined to be expected, and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: one photo of label of the driver was provided by the customer.In the photo, the part of the driver that has the label was visualized.The label was worn off and the contents were not readable.No other visual anomalies were noted of the internal component.The elevation driver serial number 91009871 was received at the bd-bard global service & repair.The elevation driver was visually inspected upon receipt and was found to be damaged.The device was functionally tested and passed the tests.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the reported label is illegible issue.The root cause for reported label is illegible issue could not be determined based on the provided information.Labeling review: the labelling/packaging review was not required as the reported event is not associated with a labelling, packaging, or use related issue.E1, g2, 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.
Event or Problem Description
It was reported that the elevation device sticker is illegible as the sticker has worn off.

• Brand Name: ELEVATION BREAST BIOPSY SYSTEM DRIVER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FERROSAN MEDICAL DEVICES SP. Z.O.O.; ul. koksowa 3; 70-031 szczecin ; PL
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22395472
• Report Number: 2020394-2025-00967
• Device Sequence Number: 8930366
• Product Code: KNW
• UDI-Device Identifier: 00801741182365
• UDI-Public: (01)00801741182365
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K192948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: EVDRIVER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown