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

Catalog Number	2016MSK
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a computed tomography guided lung biopsy through normal density tissue, the coaxial needle was allegedly broke at the hub during the second sample attempt.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: received one mission disposable core biopsy stylet for evaluation.During visual evaluation, the device appeared to be clean.A trocar stylet was received, the hub was noted to be missing, and no other components were returned.The proximal part of the needle that attaches to the hub was views under the microscope.The adhesive was noted to be non-homogeneous all around the proximal part of the needle.Further functional testing was not performed due to the condition of the returned sample and nature of the complaint.Therefore, the investigation is confirmed for the identified detachment of device or device component issue as the hub detached from the trocar stylet and noted to be missing.And the investigation is unconfirmed for the reported break issue as no other anomalies were noted.A definitive root cause for the reported break and the identified detachment of device or device component issues 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.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: 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: 21357170
• Report Number: 2020394-2025-00159
• Device Sequence Number: 20941272
• Product Code: KNW
• UDI-Device Identifier: 00801741097096
• UDI-Public: (01)00801741097096(17)270428(10)0001569090
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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: 2016MSK
• Device Lot Number: 0001569090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 80 YR
• Patient Sex: Female
• Patient Race: White