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

Catalog Number	EVDRIVER
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device is coming in on an expired rental contract.There were no alleged deficiencies reported.Additional information received, when the device arrived at the service center the label on device was illegible and no safety or serial number could be seen.There was no reported patient contact.
Additional Manufacturer Narrative
H10: as the serial 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.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.
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: the elevation driver serial number 91015703 was received at the bd-bard global service & repair.The elevation driver was visually inspected upon receipt and was found to be in good overall condition.The charger and charger power supply were not returned.The charger power supply adapter types c, g and i were returned.The device was functionally tested and passed functional test during evaluation.Furthermore, a fault reset entry was noted on 20oct2022 and the driver shows indications of servicing testing after that date.Since the serial number is unreadable, it cannot be determined if this issue was addressed in a previous service visit.No other anomalies were identified.One photo of elevation driver was provided by the customer.Reviewed by (b)(4) on 22-aug-2025.In the photo, elevation driver had illegible label, so labelled information like catalogue number, serial number and date of manufactured were not clearly visible.No other visual anomalies were noted of the internal component.Therefore, based on the investigation review, the reported issue of label on device was illegible was determined to be confirmed.The root cause for identified illegible label issue could not be determined based on the provided information.Labelling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.G3, h6 (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 device is coming in on an expired rental contract.There were no alleged deficiencies reported.Additional information received, when the device arrived at the service center the label on device was illegible and no safety or serial number could be seen.There was no reported patient contact.

• Brand Name: ELEVATION BREAST BIOPSY SYSTEM DRIVER
• Common Device Name: REUSABLE BIOPSY
• 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: 21832323
• Report Number: 2020394-2025-00558
• Device Sequence Number: 9281097
• Product Code: KNW
• UDI-Device Identifier: 00801741182365
• UDI-Public: (01)00801741182365
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 04/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown