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

Catalog Number	1810MS
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent an ultrasound guided kidney biopsy procedure through normal density tissue using a mission instrument.After firing the device, an issue occurred with the instruments locking system following pushing the inner needle to retrieve the specimen.Slight needle movement occurred crushing the specimen.It was further reported that, without pressing the trigger button, the outer cannula released from the prime position.The procedure was completed by another device.There was no reported patient injury.
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.
Additional Manufacturer Narrative
H11: 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 18g mission disposable core biopsy instrument for evaluation.The device was received without protective tubing.Upon visualization the device appeared to have residue throughout the device and was returned in initial configuration with the cannula at the 00 mm position.There were no other visual anomalies noted on the device.Upon functional testing, the device was primed by pulling back on the plunger to the 10mm position.The plunger locked into place.The device was then primed to the 20mm position by pulling back on the plunger once more.Again, the plunger locked into place.The device was fully primed without issue.The device fired without issue and did not self activate.Therefore, the investigation is unconfirmed for the reported self-activation or keying as the received device fired without any issue and did not self-activate.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (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) 2026, a patient underwent an ultrasound guided kidney biopsy procedure through normal density tissue using a mission instrument.After firing the device, an issue occurred with the instruments locking system following pushing the inner needle to retrieve the specimen.Slight needle movement occurred crushing the specimen.It was further reported that, without pressing the trigger button, the outer cannula released from the prime position.The procedure was completed by another device.There was no reported patient injury.

• Brand Name: MISSION NEEDLE
• 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: 24427087
• Report Number: 2020394-2026-00416
• Device Sequence Number: 13198692
• Product Code: KNW
• UDI-Device Identifier: 00801741096983
• UDI-Public: (01)00801741096983(17)270328(10)0001562258
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/29/2026

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: 1810MS
• Device Lot Number: 0001562258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 06/01/2026
• 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 Sex: Unknown