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

Catalog Number	MQ1816
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records was performed.The device has not been returned to the manufacturer for evaluation.However, photos and a video 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 an ultrasound guided breast biopsy procedure through normal tissue density, the device label was allegedly mislabeled.No coaxial was used and the procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to an ultrasound guided breast biopsy through normal density tissue, the device label was allegedly mislabeled.No coaxial was used and the procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.Two electronic photos and one electronic video was provided and were reviewed.One photo shows two marquee biopsy needles for comparison in which one of the needles was noted to be that used for a mq2020 marquee needle as the needle was thinner and longer.Information provided by the manufacturer noted both mqk2020 and mq1816 were manufactured on the same day.The second photo shows the labelling information which matches with the tw details.The video shows the same as the provided photo (misassembled 20g marquee device).Based on the photo and video review, the reported labelling issue is unconfirmed, and the misassembled device was identified.Therefore, the investigation is unconfirmed for the reported labelling issue as the label information shown in the photo matches with the reported device and the investigation is confirmed for the identified misassembled device as one of the devices is noted to have a mq2020 needle with pink color indicator.A definitive root cause for the reported labelling issue could not be determined based upon the provided information.Labeling review: per 37269680 rev 2, fields 1-9 accurately reflect the information for product catalog mq1816.However, fields 11-16 could not be evaluated due to insufficient clarity in the photographs provided by the customer.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.

• Brand Name: MARQUEE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CAREFUSION D.R. 203 LTD.; zona franca las americas; km 22-e-1; santo domingo 11606 ; DR 11606
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20950360
• Report Number: 2020394-2024-01826
• Device Sequence Number: 15515052
• Product Code: KNW
• UDI-Device Identifier: 00801741097201
• UDI-Public: (01)00801741097201(11)221031(17)250928(10)0001490747
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133948
• 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): 05/09/2025

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: 09/28/2025
• Device Catalogue Number: MQ1816
• Device Lot Number: 0001490747
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2022
• 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