MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MAGNUM REUSABLE CORE BIOPSY INSTRUMENT

Catalog Number	MG1522
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the serial number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.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
A patient underwent a biopsy procedure using gamma finder, magnum instrument.It was reported that the magnum device fires spontaneously from time to time.There was no patient involvement.Additional information was provided that the biomed discovered during cleaning of the magnum device, it would fully lock into the second priming position showing a full red indicator, with an audible click, and then fire immediately.
Additional Manufacturer Narrative
H11: manufacturing review: a dhr and manufacturing review was not required as the event was determined to be expected, and the investigation did not identify any manufacturing and/or service related issues.Investigation summary: the magnum driver was received for evaluation.The magnum driver was visually inspected upon receipt and was found to be in normal condition.The device was functionally tested and failed the tests due to cannula and stylet sled force being too high and out of specification.However, the device works fine and does not shoot on its own identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device fires spontaneously issue and the investigation is determined to be confirmed for the identified cannula and stylet sled force being too high issue.The root cause for reported device fires spontaneously issue cannot be determined as the problem could not be reproduced.The root cause for identified cannula and stylet sled force being too high issue could not be determined based on 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 (device, 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
A patient underwent a biopsy procedure using gamma finder, magnum instrument.It was reported that the magnum device fires spontaneously from time to time.There was no patient involvement.Additional information was provided that the biomed discovered during cleaning of the magnum device, it would fully lock into the second priming position showing a full red indicator, with an audible click, and then fire immediately.

• Brand Name: BARD MAGNUM REUSABLE CORE BIOPSY INSTRUMENT
• 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: 24257314
• Report Number: 2020394-2026-00131
• Device Sequence Number: 18220086
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945(17)260131
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K934371
• 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): 03/03/2026

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 Expiration Date: 01/31/2026
• Device Catalogue Number: MG1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown