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

Catalog Number	MQK1210
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Self-Activation or Keying (1557); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a breast biopsy procedure, the device was test fired before using needle gun cocked, the needle allegedly shot out of the device across room.Reportedly, the whole stylet needle allegedly flew out of the device and hit the wall.There was no patient contact.
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.H10: d4 (expiry date: 06/2026).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.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: received one marquee disposable core biopsy instrument in two pieces.Upon visual evaluation the device appeared to be clean and the penetration depth marker was set to 25mm.The device was received completely energized with the stylet separated from the cutting cannula.A rear scarf is applicable for 12g marquee, the stylet was inspected and no rear scarf/backend notch was noted.Due to the condition of the sample, functional testing could not be performed.One electronic photo was provided and reviewed.In that photo, one marquee biopsy device was shown in which the stylet part of the needle was noted to be detached from the marquee device.Based on the photo review, the reported detachment of device or device component can be confirmed.Therefore, based on the photo review and sample evaluation results, the investigation is confirmed for the reported detachment issue as the device was received with the stylet separated from the cutting cannula and the investigation is also confirmed for the identified non-standard device as no rear scarf/backend notch was noted in the stylet.A definitive root cause for the reported detachment of the device is determined to be component failure and identified non-standard device is determined to be manufacturing issue.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.H3 other text : see h10.
Event or Problem Description
It was reported that prior to a breast biopsy procedure, the device was test fired before using needle gun cocked, the needle allegedly shot out of the device across room.Reportedly, the whole stylet needle allegedly flew out of the device and hit the wall.There was no patient contact.

• Brand Name: MARQUEE KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 18464591
• Report Number: 2020394-2023-01369
• Device Sequence Number: 17928456
• Product Code: KNW
• UDI-Device Identifier: 00801741097263
• UDI-Public: (01)00801741097263
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/06/2024

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: MQK1210
• Device Lot Number: 0001523914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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