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

Catalog Number	MQK1410
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent an ultrasound guide breast biopsy procedure using the marquee.During the procedure, the device coaxial portion was defective and unusable.The green plastic portion was not attached to the inner stylet.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: received one coaxial cannula with a detached trocar stylet and a depth stop.Upon visual inspection, the complaint sample was received without protective tubing.The complaint sample appeared to be clean.The stylet needle hub was noted to be detached from the proximal end of the needle.The proximal end of the needle was inspected, and the sandblasting was noted to be non homogeneous.Upon functional testing: due to the nature of the complaint, functional testing was not performed.Therefore, the investigation is confirmed for the reported failure as the stylet needle hub was noted to be detached from the proximal end of the needle.A definitive root cause for the detachment of device or device component could be by manufacturing based upon the provided information.Apa 11709275 was investigated following a coaxial stylet hub detachment observed in a mission needle.Because the stylet to hub bonding process is performed on the same uv curing line used for marquee needles, marquee coaxial stylets were included within the capa scope.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (component, 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent an ultrasound guide breast biopsy procedure using the marquee.During the procedure, the device coaxial portion was defective and unusable.The green plastic portion was not attached to the inner stylet.The procedure was completed using another device.There was no reported patient injury.

• 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: 23345070
• Report Number: 2020394-2025-01706
• Device Sequence Number: 9470765
• Product Code: KNW
• UDI-Device Identifier: 00801741097287
• UDI-Public: (01)00801741097287(11)250819(17)280628(10)0001630495
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: MQK1410
• Device Lot Number: 0001630495
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• 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