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

Catalog Number	2020MS
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
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 is currently being performed.The device has not been returned to the manufacturer for evaluation.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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a biopsy procedure with the mission device.Prior to the procedure, discrepancy noted between delivery note and label in the packing.On delivery note, sterility date is (b)(6) 2027 and on the label of actual product is (b)(6) 2025.There was no patient contact.
Event or Problem Description
On (b)(6) 2025, a patient underwent a biopsy procedure with the mission device.Prior to the procedure, a discrepancy was noted between the delivery note and label in the packing.On the delivery note, the sterility date is 18/4/2027 and on the label of the actual product is 28/5/2025.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 the bd sales document and three carton boxes.The carton boxes show the product labelling information, the product label reflects catalogue number; 2020 ms, lot # 0001540159, exp date: 28/05/2025 which does match and verifies with tw.The document within the photo is not provided by the manufacturing site.Based on the photo review, the reported event cannot be confirmed.No anomalies were noted in the photo provided per label, carton mission disposable core biopsy instrument/kit.Therefore, the investigation is unconfirmed or the reported failure as the provided label meets the specification of the labelling document.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.D4 (medical device expiration date, unique identifier (udi) #), g2, 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
• 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: 22562895
• Report Number: 2020394-2025-01055
• Device Sequence Number: 14451517
• Product Code: KNW
• UDI-Device Identifier: 00801741097041
• UDI-Public: (01)00801741097041(11)220815(17)250528(10)0001540159
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 Expiration Date: 05/28/2025
• Device Catalogue Number: 2020MS
• Device Lot Number: 0001540159
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2022
• 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