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

Catalog Number	MN1213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a biopsy procedure using a magnum instrument.During the procedure, it was reported that the cannula hub was fractured and/or crumbled, compromising its integrity and preventing the procedure from being safely continued.There was no reported patient injury.
Additional Manufacturer Narrative
H11: based on the provided photograph, it was confirmed that the issue involved a cannula hub break rather than a needle break.Based on this updated information, the complaint was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Two electronic photos were provided and reviewed.First photo is the zoomed-in version of the second photo, and both the photos shows one magnum needle, and the cannula hub of magnum needle was noted be broken.Based on the photo review, the reported hub break can be confirmed.Therefore, the investigation is confirmed for the reported hub break as a break was noted on the cannula hub.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.B3.The date received by manufacturer has been used for this field.B5, 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50560492
• Report Number: 2020394-2026-02357
• Device Sequence Number: 9956133
• Product Code: FCG
• UDI-Device Identifier: 00801741084218
• UDI-Public: (01)00801741084218(17)280930(10)REKX0551
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: MN1213
• Device Lot Number: REKX0551
• 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: 08/11/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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