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

Catalog Number	1816MSK
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
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 device 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
On (b)(6) 2025, a patient underwent a biopsy procedure using the mission.During the procedure, the device needle separated at the seams.The procedure was completed by using another device.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a biopsy procedure using the mission.During the procedure, the device needle separated at the seams.The procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: received one mission disposable core biopsy kit.Following components received: one (1) mission disposable core biopsy instrument, one (1) depth stop and 0ne (1) 10mm adapter.On visual evaluation, the mission disposable core biopsy instrument was received with protective tubing.The mission disposable core biopsy instrument appeared to have residue throughout the case.The mission disposable core biopsy instrument was returned in initial configuration with the cannula at the 00 mm position.There appeared to be very slight gap between the uppercase half and the lowercase half.On microscopic visual observation, it was noted the upper case half front prongs were noted to not be fully engaged with the lowercase half housing.The device was disassembled while preserving the front prongs condition and it was noted the front prongs were bent inward.Due to the complaint reporting break, no functional testing was performed.Therefore, the investigation is unconfirmed for the reported break as no break was observed to the device and the investigation is confirmed for the identified material twisted/bent as it was noted the front prongs were bent inward.A definitive root cause for the break and identified material twisted/bent 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 (device, component, method, result, conclusion).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: 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: 23775355
• Report Number: 2020394-2025-02157
• Device Sequence Number: 10131797
• Product Code: KNW
• UDI-Device Identifier: 00801741097065
• UDI-Public: (01)00801741097065(11)251017(17)280828(10)0001641030
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 1816MSK
• Device Lot Number: 0001641030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2025
• 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