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

Catalog Number	MQK1410
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	12/18/2024
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 device has been returned to the manufacturer for evaluation.However, a video 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 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, the outer cannula of the device was allegedly not attached to the biopsy system.It was further reported that the stylet was allegedly detached from the needle.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 procedure, the outer cannula of the device was allegedly not attached to the biopsy system.It was further reported that the stylet was allegedly detached from the needle.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: one video was provided and reviewed.The video shows that health care professional demonstrating the sliding motion of the cannula from a marquee device.The video clearly shows that the cannula is detached and does not appear to have a flared end.Based on the video review the reported issue detachment of device and identified nonstandard device can be confirmed.One marquee disposable core biopsy instrument was received for evaluation.During visual evaluation, the device appeared to be clean.The penetration depth marker was set to 25mm.The device was received in its initial position.The distal tip of the stylet was not seen protruding from the distal end of the cannula.The device was received with the cannula separated from the needle assembly.Upon functional testing, the cannula was inspected, and sand blasting was noted to not be homogeneous at the rear scarf.Due to the condition of the sample and the nature of the complaint, functional testing was not performed.Therefore, the investigation is confirmed for the reported detachment of device or device component as cannula detached from the needle assembly and the investigation is confirmed for the identified nonstandard device as sand blasting was noted to not be homogeneous at the rear scarf and does not appear to have a flared end (missing flare).The definitive root cause for the reported detachment of device or device component observed to be a component failure and the definitive root cause for the identified nonstandard device was observed to be a manufacturing related.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (device, method).H11: d4 (unique identifier (udi) #), h6 (result, conclusion).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.

• Brand Name: MARQUEE KIT
• 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: 21157249
• Report Number: 2020394-2024-02013
• Device Sequence Number: 7631517
• Product Code: KNW
• UDI-Device Identifier: 00801741097287
• UDI-Public: (01)00801741097287(11)240419(17)270228(10)0001558519
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: MQK1410
• Device Lot Number: 0001558519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2024
• 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