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

Catalog Number	2010MSK
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent a lung biopsy procedure using mission needle.During a computed tomography guided lung biopsy, the needle detached from the tip and the detached needle is inside the patient's rib cage.Coaxial was used.The incident occurred during the proceedings, precisely towards the end of the proceedings.The removal of the stake is the last step in the procedure before the skin dressing is applied.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: 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 lung biopsy procedure using mission needle.During a computed tomography guided lung biopsy, the needle detached from the tip and the detached needle is inside the patient's rib cage.Coaxial was used.The incident occurred during the proceedings, precisely towards the end of the proceedings.The removal of the stake is the last step in the procedure before the skin dressing is applied.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the detachment of the device could not be determined based upon the provided information.It is unknown whether patient and/or 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.G3, h6 (method).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: 22095413
• Report Number: 2020394-2025-00811
• Device Sequence Number: 6917227
• Product Code: KNW
• UDI-Device Identifier: 00801741097089
• UDI-Public: (01)00801741097089(11)240612(17)270428(10)0001568969
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2010MSK
• Device Lot Number: 0001568969
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown