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

Catalog Number	2010MSK
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, photos were provided for review the investigation of the reported event is currently underway.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 a biopsy procedure using the mission device.It was reported that during the procedure, the needle allegedly broken.It was further reported that another needle also broken but not used on patient.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a 66-year-old female patient underwent an ultrasound guided lymph biopsy procedure through normal tissue using the mission device.Post procedure, it was reported that the needle was allegedly broken.No coaxial needle was used.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.One electronic photo was provided and reviewed.The photo shows one mission kit.The device was placed in the needle holder with dept 20mm in fully primed position.The trocar stylet was placed, needles and syringe and cotton with blood residues in a tray.A break as well as bent was noted in the coaxial needle.Therefore, the investigation is unconfirmed for the reported detachment issue as no component detachment was noted in the photo.However, the investigation is confirmed for the identified break and bent as the coaxial needle was noted to be broken and bent in the provided photo.A definitive root cause for the reported detachment, identified break and material 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.A2, a3a, b5, d4 (medical device lot number, unique identifier (udi) #), g3, h6 (device, 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.

• 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: 23835891
• Report Number: 2020394-2025-02198
• Device Sequence Number: 5093619
• Product Code: KNW
• UDI-Device Identifier: 00801741097089
• UDI-Public: (01)00801741097089(11)250322(17)280128(10)0001610454
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 2010MSK
• Device Lot Number: 0001610454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2025
• 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 Age: 66 YR
• Patient Sex: Female