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

Catalog Number	1820MSK
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigational summary: received one mission disposable core biopsy kit which included one mission disposable core biopsy instrument, one compatible coaxial and a blunt stylet for evaluation.Upon visualization, the trocar stylet separated from the stylet hub was inspected under a microscope, and the sandblasting was noted to be non-homogeneous at the proximal end of the trocar stylet.During functional testing, the device was fully primed without issue.The device was then inserted into an apple without issue.The device was further tested by cocking and firing the device 10 times into an apple at each penetration depth, for a total of 20 tests.The device was able to prime, advance and fire properly.All 20 samples were obtained without issue.Therefore, the investigation is unconfirmed for the reported failure to fire as the device was able to prime, advance and fire properly.All 20 samples were obtained without issue.However, the investigation is confirmed for the identified detachment as the stylet was detached from the stylet hub.A definitive root cause for the identified detachment of device or device component was traced to be manufacturer related.However, a definitive root cause for the reported failure to fire issue could not be determined based upon the provided information.It is unknown whether procedural issues contributed to the reported event.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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
On (b)(6) 2025, a patient underwent an ultrasound guided liver biopsy procedure through normal density tissue using a mission biopsy kit.Prior to the procedure, the outer cannula couldn't be fired.The procedure was completed by another device.There was no patient contact.

• Brand Name: MISSION KIT
• 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: 24884821
• Report Number: 2020394-2026-00928
• Device Sequence Number: 10420357
• Product Code: KNW
• UDI-Device Identifier: 00801741097072
• UDI-Public: (01)00801741097072(11)240829(17)270528(10)0001579299
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K171953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: 1820MSK
• Device Lot Number: 0001579299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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