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

Catalog Number	MQ1410
Medical Device Problem Codes	Failure to Prime (1492); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one marquee disposable core biopsy instrument was received for evaluation.During visual observation, device appeared to have residue throughout the cannula and the device was received in a fully primed position.There were no other anomalies were noted to the device.Upon functional testing, an attempt was made to fire the device, but the device failed.Therefore, the device was disassembled, and resistance was felt while removing the stylet from the cannula.On dimensional observation, the outer diameter of the cannula and the stylet were measured, and measurements were within the acceptable range.Upon viewing the cannula and stylet under microscope, clear residue material was noted within the cannula and on the stylet.The material was sent for analysis and the results identified the clear residue material as a known material used during the production of marquee instruments.Therefore, the investigation is confirmed for the reported failure to prime as resistance was felt.And the investigation is confirmed for the identified device contamination with chemical or other material issue as the clear residue material was noted within the cannula and on the stylet.The definitive root cause for the reported failure to prime was determined to be the identified residue material causing resistance between the stylet and cannula.Furthermore, the definitive root cause for the identified residue material was determined to be manufacturing related.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 05/2025).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 during a biopsy procedure, the device allegedly failed to prime.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 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: 19103296
• Report Number: 2020394-2024-00508
• Device Sequence Number: 20684844
• Product Code: KNW
• UDI-Device Identifier: 00801741097133
• UDI-Public: (01)00801741097133
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Report Date (Section B): 04/12/2024

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: MQ1410
• Device Lot Number: 0001473844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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