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

Model Number	MQK1410
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.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.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2025).
Event or Problem Description
It was reported that prior to a biopsy procedure, it was noticed that the packaging was opened.It was further reported that the package was not sealed so the sterility of the package was compromised.The procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to a biopsy procedure, it was noticed that the packaging was opened.It was further reported that the package was not sealed so the sterility of the package was compromised.There was no patient contact.
Additional Manufacturer Narrative
H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.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: one unsealed marquee disposable core biopsy instrument for the evaluation.Upon visual evaluation, the device was appeared to be clean and the device was returned half-energized revealing the sample notch.The penetration depth marker was set to 25mm.Also, it was noted that no breaks were identified on the device.Upon functional testing, the device was fired using both semi-automatic and the automatic button and strong force was felt at the 18mm and 25mm marks.Therefore, the investigation is inconclusive for the reported unsealed device packaging issue as the returned condition of the device appears that the device may have been used and also no other objective evidence was provided for review to confirm the reported event.A definitive root cause for the alleged unsealed device packaging issue 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.H10: d4 (expiry date: 08/2025), g3.H11: b3, e1, h6 (method, result, conclusion).H11: 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.H3 other text : see h10.
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 unsealed marquee disposable core biopsy instrument for the evaluation.Upon visual evaluation, the device was appeared to be clean and the device was returned half-energized revealing the sample notch.The penetration depth marker was set to 25mm.Therefore, the investigation is inconclusive for the reported unsealed device packaging issue as the returned condition of the device appears that the device may have been used and also no other objective evidence was provided for review to confirm the reported event.A definitive root cause for the alleged unsealed device packaging issue 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.H10: d4 (expiry date: 08/2025).H11: 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
It was reported that prior to a biopsy procedure, it was noticed that the packaging was opened.It was further reported that the package was not sealed so the sterility of the package was compromised.There was no patient contact.

• 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: 16748417
• Report Number: 2020394-2023-00255
• Device Sequence Number: 12905570
• Product Code: KNW
• UDI-Device Identifier: 00801741097287
• UDI-Public: (01)00801741097287
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 01/11/2024

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 Model Number: MQK1410
• Device Catalogue Number: MQK1410
• Device Lot Number: 0001485928
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 09/28/2023; 01/11/2024
• Initial Report FDA Received Date: 04/15/2023
• Supplement Report FDA Received Date: 09/29/2023; 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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