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

Catalog Number	2016MSK
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient was prepped for a disposable biopsy procedure using through the mission device.Prior to the procedure, it was reported that the plastic top of the device had allegedly come off.There was no patient contact.
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 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 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: two electronic photos were provided and reviewed.The first photo shows the product labelling information which does match and verifies with tw.The second photo shows the one trocar stylet hub was noted to be detached from its needle and wrapped with tape kept outside the package.No other visual anomalies are observed.Based on the provided photo, the reported detachment can be confirmed.Received one trocar stylet for evaluation.The device appeared to be clean and was received with protective tubing.Upon visualization the trocar stylet appeared to be detached from the trocar stylet hub and the stylet was returned.The proximal end of the needle was inspected, and the sandblasting was noted to be non-homogeneous.Due to the complaint reporting, "detachment of device" no functional testing was performed.Therefore, based on the photo review and evaluation results, the investigation is confirmed for the reported detachment of device or device components as the detachment of stylet hub from the needle.A definitive root cause for the detachment of the device was traced to manufacturing related issue.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 (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.
Event or Problem Description
On (b)(6) 2025, a patient prepped for a disposable biopsy procedure using through the mission device.Prior to the procedure, it was reported that the plastic top of the device had allegedly come off.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: two electronic photos were provided and reviewed.The first photo shows the product labelling information which does match and verifies with tw.The second photo shows the one trocar stylet hub was noted to be detached from its needle and wrapped with tape kept outside the package.No other visual anomalies are observed.Based on the provided photo, the reported detachment can be confirmed.Received one trocar stylet for evaluation.The device appeared to be clean and was received with protective tubing.Upon visualization the trocar stylet appeared to be detached from the trocar stylet hub and the stylet was returned.The proximal end of the needle was inspected, and the sandblasting was noted to be non-homogeneous.Due to the complaint reporting, "detachment of device" no functional testing was performed.Therefore, based on the photo review and evaluation results, the investigation is confirmed for the reported detachment of device or device components as the detachment of stylet hub from the needle.A definitive root cause for the detachment of the device was traced to manufacturing related issue.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B2, b5, g3.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 prepped for a biopsy procedure using through the mission device.Prior to the procedure, it was reported that the plastic top of the device had allegedly come off.There was no patient contact.

• 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: 23955543
• Report Number: 2020394-2025-02321
• Device Sequence Number: 14855382
• Product Code: KNW
• UDI-Device Identifier: 00801741097096
• UDI-Public: (01)00801741097096(11)251017(17)280828(10)0001638427
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,Followup
• Report Date (Section B): 02/17/2026

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: 2016MSK
• Device Lot Number: 0001638427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 02/06/2026; 02/06/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/17/2026; 02/17/2026
• 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