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

Catalog Number	1610MS
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
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 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 provided 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
A patient was getting prepared for a biopsy procedure using the mission needle.Prior to the procedure, it was reported that the device had two labels.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: the physical device was not returned for evaluation.One electronic photo was received and reviewed.The photo shows a mission product carton and shows the actual product labeling applied at the manufacturing facility containing all correct product information for product catalog 1616ms and lot number 0001637938.The provided photo also shows the nationalization labeling that is applied at the bd brazil distribution center prior to release in brazil.This label contains a different product catalog 1610ms and lot 0001633398.This nationalization label is added to provide product information in the national language.The product information included on this label was incorrect and does not match the actual product information on the manufacturing product label.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.Therefore, the investigation is confirmed for the reported device markings / labeling problem as the bd brazil distribution center placed the incorrect nationalization label on the device.The definitive root cause for the reported device markings/ labelling problem was identified to be distribution related.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.B3, b5, d4 (unique identifier (udi) #), g3, h6 (component, method, result, conclusion).Section a through f: the information provided 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
A patient was getting prepared for a biopsy procedure using the mission biopsy device was found to have two different labels applied, one for ref 1610ms (batch 0001633398) and another for ref 1616ms (batch 0001637938).It was reported that the physical product inside the packaging was 1616ms, which does not match the invoiced or expected.There was no patient contact.

• Brand Name: MISSION
• 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: 24302070
• Report Number: 2020394-2026-00219
• Device Sequence Number: 12072223
• Product Code: KNW
• UDI-Device Identifier: 00801741096969
• UDI-Public: (01)00801741096969(11)250905(17)280728(10)0001633398
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K171953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 1610MS
• Device Lot Number: 0001633398
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2025
• 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