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

Catalog Number	MG1522
Medical Device Problem Codes	Material Discolored (1170); Self-Activation or Keying (1557); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was prepped for the biopsy procedure using the magnum.Prior to the procedure, the magnum gun fires on its own.No coaxial needle was used.There was no patient contact.
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 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: 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 serial number vtfw0134 was received at the can - samples bard canada.The magnum driver was visually inspected upon receipt and was found to be in good overall condition.The sleds, switch ring bearing, and cocking slide are worn and discolored.The device was functionally tested and passed the tests during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported fire on its own issue, and the investigation is determined to be confirmed for the identified sleds, switch ring bearing, and cocking slide are worn and discolored issue.The root cause for reported fire on its own issue cannot be determined as the problem could not be reproduced.The root cause for identified sleds, switch ring bearing, and cocking slide is worn issue could not be determined based on the provided information.The root cause for identified sleds, switch ring bearing, and cocking slide is discolored issue could not be determined based on the provided information.Labeling review: the labelling/packaging review was not required as the reported event is not associated with a labelling, packaging, or use related issue.G3, h6 (device, component, 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 was prepared for the biopsy procedure using the magnum device.Prior to the procedure, the magnum gun fires on its own.No coaxial needle was used.There was no patient contact.

• Brand Name: MAGNUM INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): LAVELLE MACHINE; 485 groton road; westford 01886
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23723891
• Report Number: 2020394-2025-02094
• Device Sequence Number: 18798940
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/18/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: MG1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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