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

Catalog Number	MG1522
Medical Device Problem Codes	Material Discolored (1170); Device Difficult to Setup or Prepare (1487); Self-Activation or Keying (1557); Component Missing (2306); Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot 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 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
It was reported that the magnum driver is firing on its own.It was further reported that the driver is able to fully prime but fired on its own without pressing the trigger after first time cocking.The device was fired immediately as the user released the finger from the cocking slide.The safety lever was in "f" position.There was no reported patient injury.
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.The magnum driver was visually inspected upon receipt and was found there is screw missing on the rear cover and the cover is not fully flush with the main body.Also, during disassembly it was found the main body is deformed on the inside, latch plate it was hard to remove.Cocking slide worn and discolored.The device was functionally tested and passed all test the cannula sled required more force to latch in place, or it will return neutral and minimum cycle test failed.However the stylet sled latches as normal and the gun fires normal identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device firing on its own issue, and the investigation is determined to be confirmed for the identified cocking slide worn and discolored issue, and the investigation is determined to be confirmed for the identified missing screw issue and the investigation is determined to be confirmed for the identified cannula sled required more force to latch in place issue and the investigation is determined to be confirmed for the identified main body deformed inside issue.The root cause for reported firing on its own issue cannot be determined as the problem could not be reproduced.The root cause for identified cocking slide worn issue could not be determined based on the provided information.The root cause for identified cocking slide discolored issue could not be determined based on the provided information.The root cause for identified missing screw failed issue could not be determined based on the provided information.The root cause for identified cannula sled required more force to latch in place issue could not be determined based on the provided information.The root cause for identified main body deformed inside 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 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
A patient underwent a biopsy procedure using magnum instrument.It was reported that the magnum driver is firing on its own.It was further reported that the driver is able to fully prime but fired on its own without pressing the trigger after first time cocking.The device was fired immediately as the user released the finger from the cocking slide.The safety lever was in "f" position.There was no reported patient injury.

• 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: 23081113
• Report Number: 2020394-2025-01512
• Device Sequence Number: 18658141
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945
• 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): 11/04/2025

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 Catalogue Number: MG1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 09/18/2025
• 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