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.Photo was 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 using the magnum.During the procedure, the device needle allegedly broke.There was no reported patient injury.
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 provided and reviewed.The photo shows that the magnum needle both cannula and stylet hub was noted to be broken and small broken piece found.One labelling photo was provided and reviewed label details are matches with track wise.Based on the photo review, the reported break issue can be confirmed for only one device.Two magnum biopsy needles were received for evaluation.During visual evaluation, sample 1, upon visual evaluation, received without protective tubing and no spacer attached to the needle at the hubs.The magnum biopsy needle appeared to have residue throughout.The stylet and cannula hub was broken with the detached pieces returned.The sample notch was not exposed at the distal end.Sample 2: upon visual evaluation, received without protective tubing and no spacer attached to the needle at the hubs.The magnum biopsy needle appeared to have residue throughout.The stylet and cannula hubs were broken with the detached pieces returned.The device was received with the sample notch exposed.Due to the complaint reporting "break" no functional testing was performed.Therefore, the investigation is confirmed for the reported break as the stylet and cannula hubs were broken in sample 1 with the detached pieces returned.And the investigation is confirmed for the reported break as the cannula hubs were broken in sample 2 with the detached pieces returned.A definitive root cause for the alleged break issue could not be determined based upon the provided information.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.

• 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: 23590575
• Report Number: 2020394-2025-01899
• Device Sequence Number: 13330286
• 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: 10/27/2025
• 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