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

Catalog Number	MQ1410
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
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 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) 2026, a patient underwent a biopsy procedure using the marquee instrument.It was reported that during the second biopsy attempt, the cannula (graduated portion) remained inside the breast.A subsequent attempt was made outside the breast, during which the trocar allegedly released unexpectedly and shot toward the wall.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2026, a patient underwent a biopsy procedure using the marquee instrument.It was reported that during the second biopsy attempt, the cannula (graduated portion) remained inside the breast.A subsequent attempt was made outside the breast, during which the trocar allegedly released unexpectedly and shot toward the wall.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: received one 14g marquee disposable core biopsy instrument for evaluation.The device was received with protective tubing.Upon visualization the device appeared to have residue throughout the needle and was received in the initial position.The penetration depth marker was set to 25mm.It was observed that the cannula was noted to be detached from the cannula hub.The cannula was inspected under a microscope, and the sandblasting was noted to be non-homogeneous at the proximal end.Due to the detached cannula, functional testing was not performed.Upon dimensional observation, the actual outer diameter of the cannula "df" was measured and found to be not within the acceptable range.Therefore, the investigation is confirmed for the reported detachment of device or device component as the cannula was noted to be detached from the cannula hub and the investigation is confirmed for the identified non-standard device as the specification for the outer cannula diameter (df) was not within the acceptable range.The out-of-specification outer diameter of the cannula may have contributed to the reported event; however, the definitive root cause has not been identified for the reported detachment of device or device component issue.A definitive root cause for the identified non-standard device issue could be manufacturing related.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4.(unique identifier (udi) #), g3, h6 (device, component, method, result, conclusion).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: 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: 24517271
• Report Number: 2020394-2026-00604
• Device Sequence Number: 13192482
• Product Code: KNW
• UDI-Device Identifier: 00801741097133
• UDI-Public: (01)00801741097133(11)251019(17)280828(10)0001639847
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: MQ1410
• Device Lot Number: 0001639847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2025
• 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