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

Catalog Number	MG1522
Medical Device Problem Codes	Self-Activation or Keying (1557); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
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 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.
Event or Problem Description
It was reported that a patient underwent a prostate biopsy using magnum device.And prior to the procedure the magnum device sometimes does not lock in priming position, and fire by itself.There is no patient involvement.Additional information received, the device was jamming during the priming process.
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 at the novatecnica.The magnum driver was visually inspected and was found to be in normal condition.Rear body is worn out.The device was functionally tested and passed all the tests during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device fire by itself issue and the investigation is determined to be confirmed for the identified rear body worn out issue.The root cause for reported device fire by itself issue cannot be determined as the problem could not be reproduced.The root cause for identified rear body worn out 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.D4 (unique identifier (udi) #), e1, g2, 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
It was reported that a patient underwent a prostate biopsy using magnum device.And prior to the procedure the magnum device sometimes does not lock in priming position, and fire by itself.There is no patient involvement.Additional information received, the device was jamming during the priming process.

• 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: 23060595
• Report Number: 2020394-2025-01501
• Device Sequence Number: 18604325
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945(17)181113
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K934371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 11/13/2018
• Device Catalogue Number: MG1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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