MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Magnum Needle; Biopsy Instrument

Catalog Number	MN1413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent biopsy procedure using the magnum instrument.Prior to the procedure, the biopsy gun was tested without the needle and was found to be functioning properly.During the procedure, four tissue fragments were collected, however, the needle subsequently broke, requiring replacement with another needle.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 return of the sample is pending.The investigation of the reported event is currently underway.E1: (b)(6).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.

• Brand Name: Magnum Needle
• Common Device Name: Biopsy Instrument
• Manufacturer (Section D): Bard Peripheral Vascular, Inc.; 1625 w 3rd st.; tempe 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50866594
• Report Number: 2020394-2026-02797
• Device Sequence Number: 10661883
• Product Code: FCG
• UDI-Device Identifier: 00801741084256
• UDI-Public: (01)00801741084256(11)250808(17)280630(10)REKU3170
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K934370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2026

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: MN1413
• Device Lot Number: REKU3170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• 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