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

Catalog Number	1616MS
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was prepped for a biopsy procedure by using mission instrument.It was reported that prior to the procedure the device allegedly had labelling problem.There was no patient involvement was reported.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not 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.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: one electronic photo was received and reviewed.The photo shows the product labeling information, which matches the trackwise details; however, the barcode is not clearly visible.Therefore, the investigation is considered inconclusive due to the poor quality of the provided photo and insufficient evidence to confirm the reported failure.A definitive root cause for the reported device markings/ labelling problem could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.By comparing the received label against document label, carton end, mission disposable core biopsy instrument/kit global, it was noted that the catalogue number, pk number, gauge size & needle length, lot number characters, use by date format, gtin number which was mentioned in the label was verified and it matched with the document.No anomalies were noted in the provided label photo.D4 (medical device lot, medical device expiration date, unique identifier (udi) #), g2, g3, h6 (component, method).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
A patient underwent a biopsy procedure using mission instrument.Prior to the procedure the device allegedly had labelling problem.There was no patient contact.

• 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: 24289957
• Report Number: 2020394-2026-00195
• Device Sequence Number: 18493837
• Product Code: KNW
• UDI-Device Identifier: 00801741096976
• UDI-Public: (01)00801741096976(11)240907(17)270728(10)0001581141
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 1616MS
• Device Lot Number: 0001581141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2024
• 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