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

Catalog Number	2016MSK
Medical Device Problem Codes	Failure to Prime (1492); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent a lung biopsy procedure using mission kit instrument.During the procedure the biopsy needle couldn't be cocked and the needle broke and was stuck inside patient¿s body.Additionally, the sample was trapped inside the needle.The procedure was completed by using another device.There was no patient reported injury.The current patient status is unknown.
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 lung biopsy procedure using mission kit instrument.During the procedure the biopsy needle couldn't be cocked and the needle broke and was stuck inside patient¿s body.After activating the biopsy needle, the biopsy needle cover was detached.Additionally, the sample was trapped inside the needle.The procedure was completed by using another device.The current patient status is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: five electronic photos were provided and reviewed.The first photo shows the labelling information of the device which was cross verified with the tw details.The second photo shows the hcp holding mission cover.The third photo shows the one mission device with the needle, a coaxial needle and a needle protector is seen beside the device.The fourth photo shows the one mission device with the needle, a coaxial needle and two needle protector is seen beside the device.The fifth photo shows the mission kit inside the taped package.Received one mission disposable core biopsy instrument and a blunt stylet.On visual evaluation, the mission disposable core biopsy instrument was received with protective tubing.The mission disposable core biopsy instrument appeared to be clean.The upper case half of the mission disposable core biopsy instrument appeared to be detached and was returned.The sample notch was not exposed.The position of the mission disposable core biopsy instrument could not be determined.On microscopic visual observation, the upper case half was noted to be separated from the device, and the spring was noted to be protruding from the back of the outer housing.And the upper case half front prongs were noted to be slightly bent inwards and slight damage was noted to one of the front prongs.Due to the condition of the returned device, functional testing was not performed.Therefore, the investigation remains inconclusive for the reported failure to prime and difficult to remove issue as functional testing could not be performed due to returned condition of the device.The investigation is confirmed for the reported detachment as the upper case half of the device was detached and returned.Also, the investigation is confirmed for the identified material twisted/bent as the upper case half prongs were noted to be slightly bent.The definitive root cause for reported detachment can be determined as component failure.However, a definitive root cause for the reported failure to prime, difficult to remove 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.B5, 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): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22847107
• Report Number: 2020394-2025-01298
• Device Sequence Number: 8403634
• Product Code: KNW
• UDI-Device Identifier: 00801741097096
• UDI-Public: (01)00801741097096(11)250317(17)280128(10)0001611842
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/03/2026

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: 2016MSK
• Device Lot Number: 0001611842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown