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

Catalog Number	1810MS
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, a photo and video were provided for review.The investigation of the reported event is currently underway.Section a through f - the information provided by bd represents all of 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 an ultrasound guided breast biopsy procedure through hard density tissue using mission kit.During the procedure the needle was bent and difficult to remove from the patient.The procedure was completed by another device.There was no patient reported injury.
Event or Problem Description
(b)(6) 2025 a patient underwent an ultrasound guided breast biopsy through hard density tissue using mission kit.During the procedure, the needle was bent and difficult to remove from the patient.The procedure was completed by another device.There was no patient reported injury.
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.One electronic photo was provided and reviewed.The photo shows one mission device with 20 mm configuration placed on a flat surface.The needle of the device was noted to be bent.No other visual anomalies were noted.One electronic video was provided and reviewed.The video shows one mission device was held by the healthcare professional in 20 mm configuration.He rotates the device, and the needle of the device was noted to be bent.No other visual anomalies were noted.Based on the photo and video review the reported bent can be confirmed for one device.Therefore, the investigation is confirmed for the reported bent as a bent was noted on the needle of one device.However, the investigation is also inconclusive for the reported difficult to remove for first device as absence of supporting evidence.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) #), e1, 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.

• 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: 22640133
• Report Number: 2020394-2025-01114
• Device Sequence Number: 9538426
• Product Code: KNW
• UDI-Device Identifier: 00801741096983
• UDI-Public: (01)00801741096983(11)240516(17)270328(10)0001561878
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/24/2025

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: 1810MS
• Device Lot Number: 0001561878
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 08/24/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2024
• 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
• Patient Sex: Unknown