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

Catalog Number	MQ1816
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
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 sample has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Section a through f ¿ the information provide 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
During investigation of the returned sealed lot samples from the customer, it was reported that the device was found to be contaminated.There was no reported patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: five sealed marquee disposable core biopsy instruments were received (samples 1, 3 to 5, and 7).Visual inspection confirmed that all samples were sealed, therefore, no decontamination was performed.Blue particles were observed within the sealed packaging.The returned samples were evaluated by the manufacturing team and inspected by a certified quality operations inspector in accordance with procedure.All samples passed inspection.The material observed within the packaging is not considered contamination, as it matches the cannula and stylet hub material, and the quantity of particles and size were measured to be within the acceptable limits as defined.Therefore, the investigation is unconfirmed for the reported device contamination as all samples passed the inspection.A definitive root cause for the reported device contamination could not be determined based upon the provided information.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 (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
During investigation of the returned sealed lot samples from the customer, it was reported that the device was found to be contaminated.There was no patient contact.
Event or Problem Description
It was reported that during evaluation of the lot sample, blue particles were visualized in the device packaging.There was no reported patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: five sealed marquee disposable core biopsy instruments were received (samples 1, 3 to 5, and 7).Visual inspection confirmed that all samples were sealed; therefore, no decontamination was performed.Blue particles were observed within the sealed packaging.The returned samples were evaluated by the manufacturing team and inspected by a certified quality operations inspector in accordance with procedure.All samples passed inspection.The material observed within the packaging is not considered contamination, as it matches the cannula and stylet hub material, and the quantity of particles and size were measured to be within the acceptable limits defined.Therefore, the investigation is unconfirmed for the reported device contamination as all samples passed the inspection.A definitive root cause for the reported device contamination could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, e1, g2, g3.Section a through f: the information provide 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
• 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: 23875716
• Report Number: 2020394-2025-02230
• Device Sequence Number: 5712135
• Product Code: KNW
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

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: MQ1816
• Device Lot Number: 0001614541
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 04/02/2026; 04/02/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/03/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2025
• 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