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

Catalog Number	MN1416
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a biopsy procedure using the magnum.During the procedure, the device needle allegedly broke.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 was 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: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (component, 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) 2025 a patient underwent a biopsy procedure using the magnum.During the procedure, the device needle allegedly broke.There was no reported patient injury.

• Brand Name: MAGNUM NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23590573
• Report Number: 2020394-2025-01898
• Device Sequence Number: 18680858
• Product Code: FCG
• UDI-Device Identifier: 00801741084263
• UDI-Public: (01)00801741084263(11)240905(17)270531(10)REJT3475
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K934370
• 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): 12/31/2025

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: MN1416
• Device Lot Number: REJT3475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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