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

Catalog Number	EVDRIVER
Medical Device Problem Codes	Contamination (1120); Suction Problem (2170); Moisture or Humidity Problem (2986); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
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 return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H11: section a through f - the information provided by bd represents all of 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 biopsy procedure, it was noted that the device label is allegedly blank.Furthermore, there is no longer any printed information on the label.There was no patient contact.
Event or Problem Description
It was reported that prior to a biopsy procedure, it was noted that the device label is allegedly blank.Furthermore, there is no longer any printed information on the label.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a dhr and manufacturing review was not required as the serial number is unknown.Investigation summary: one photo of elevation driver was provided by the customer.In the photo, customer shows bottom view of the device with blank label.No information is visible as the label is blank.No other visual anomalies were noted of the internal component.The elevation driver serial number unknown was received at the bd-bard global service and repair.The elevation driver was visually inspected upon receipt and was found to be damaged.The back label is almost blank.The text is missing.The device was functionally tested and failed the vacuum test during evaluation.There is dried blood in the crevasses between the top and bottom housing subassembly in the tank area, silicone tubing, crevasses of the tank window.The bottom label is a ¿baw¿ label which means the label was replaced at the depot in the past.The moisture indicator is completely red, updates/upgrades required: the top housing subassembly needs replaced.The real time clock (rtc) reverted to 1/1/2000 and needs updated.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the reported device label is blank issue, the investigation is determined to be confirmed for the identified vacuum issue, the investigation is determined to be confirmed for the identified dried blood in the crevasses between top housing and bottom housing subassembly and silicone tubing and crevasses of the tank window issue, the investigation is determined to be confirmed for the identified moisture indicator is red issue.The root cause for reported device label is blank issue could not be determined based upon the information.However, to be ink from label printing was lifted from the label was identified.The root cause for identified vacuum issue could not be determined based upon the provided information.The root cause for identified dried blood in the crevasses between top housing and bottom housing subassembly and silicone tubing and crevasses of the tank window issue could not be determined based upon the provided information.The root cause for identified moisture indicator is red issue could not be determined based upon the provided information.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.H11: section a through f - the information provided by bd represents all of 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: 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: 20492272
• Report Number: 2020394-2024-01599
• Device Sequence Number: 19860033
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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