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

Catalog Number	MQ1410
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Prime (1492); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
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.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one marquee disposable core biopsy instrument was returned for evaluation.On visual evaluation, the device was received without a coaxial biopsy needle and the device appeared to have residue on the cutting cannula and the penetration depth marker was set to 25mm.And it was noted that the device was in completely energized condition and it was appeared that the stylet was stuck in the cutting cannula.It was noted that the cannula was loose and it was also noted that the cannula could easily slide of the stylet.Due to the condition of the sample received, functional testing was not performed.Additional evaluation was performed and the device was disassembled, and there were no anomalies noted to the cannula hub.It was noted that the end of the cannula was not flared.Therefore, the investigation for the identified detachment of device or device components is confirmed as the cannula was noted to be loose and not secure.The investigation is confirmed for the identified nonstandard device issue as the cannula end was found not flared.However, the investigation for the reported failure to prime is kept as inconclusive as the identified issues may have contributed to the reported issue.A definitive root cause for the alleged failure to prime could not be determined based upon the provided information.The root cause for the identified detachment of device or device component issues are likely due to the condition of the cannula (e.G., not flared).The root cause for the identified nonstandard device issue is determined to be manufacturing related.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.
Event or Problem Description
It was reported that during a biopsy procedure, the needle aperture allegedly stuck inside the outer cannula.There was no reported patient injury.
Event or Problem Description
It was reported that during a biopsy procedure, the needle aperture allegedly stuck inside the outer cannula.There was no reported patient injury.
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: one marquee disposable core biopsy instrument was returned for evaluation.On visual evaluation, the device was received without a coaxial biopsy needle and the device appeared to have residue on the cutting cannula and the penetration depth marker was set to 25mm.And it was noted that the device was in completely energized condition and it was appeared that the stylet was stuck in the cutting cannula.It was noted that the cannula was loose and it was also noted that the cannula could easily slide of the stylet.Due to the condition of the sample received, functional testing was not performed.Additional evaluation was performed and the device was disassembled, and there were no anomalies noted to the cannula hub.It was noted that the end of the cannula was not flared.Therefore, the investigation for the identified detachment of device or device components is confirmed as the cannula was noted to be loose and not secure.The investigation is confirmed for the identified nonstandard device issue as the cannula end was found not flared.However, the investigation for the reported failure to prime is kept as inconclusive as the identified issues may have contributed to the reported issue.A definitive root cause for the alleged failure to prime could not be determined based upon the provided information.It is unknown whether patient and/or procedural issues contributed to the reported event.The root cause for the identified detachment of device or device component issues are likely due to the condition of the cannula (e.G., not flared).The root cause for the identified nonstandard device issue is 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.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
• 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: 19935491
• Report Number: 2020394-2024-01184
• Device Sequence Number: 18000410
• Product Code: KNW
• UDI-Device Identifier: 00801741097133
• UDI-Public: (01)00801741097133(11)230127(17)251128(10)0001500910
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/04/2024

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 Expiration Date: 11/28/2025
• Device Catalogue Number: MQ1410
• Device Lot Number: 0001500910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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