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

Catalog Number	MG1522
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
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 was 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 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.
Event or Problem Description
The patient was prepped for a biopsy procedure using magnum instrument.It was reported that the magnum driver fires unintentionally during the reloading process.It was further reported that following the second prime attempt, the magnum driver discharged immediately after the user removed their finger from the preparation mechanism.There was no patient involvement.
Additional Manufacturer Narrative
H11: manufacturing review: a dhr and manufacturing review were not required as the event was not classified as an unexpected event, the investigation did not identify any manufacturing related issues and no repeat failures were found during the service history review.Investigation summary: the magnum driver serial number (b)(6) was received at the bip biomedizinische intstrumente und produkte gmbh.The magnum driver was visually inspected upon receipt, and it was in good condition.The device was functionally tested and passed the test during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device fires unintentionally issue.The root cause for reported device fires unintentionally issue cannot be determined as the problem could not be reproduced.Labelling 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 (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
The patient was prepped for a biopsy procedure using magnum instrument.It was reported that the magnum driver fires unintentionally during the reloading process.It was further reported that following the second prime attempt, the magnum driver discharged immediately after the user removed their finger from the preparation mechanism.There was no patient involvement.

• 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: 24854941
• Report Number: 2020394-2026-00910
• Device Sequence Number: 18459298
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945(17)290228
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K934371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: MG1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 04/22/2026
• 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