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	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a biopsy procedure using magnum driver.During the procedure, the driver self activated while retrieving the sample from the needle.Additionally, it was also clarified that the driver self activated outside the patient after the cocking slide locked at a half red or silver position.The device was then fully primed a second time; however, it clicked into place and subsequently released on its own.Tissue samples could still be collected, and no needle malfunction was reported.There was no reported patient injury.
Additional Manufacturer Narrative
H11: b3: the actual date of event is unknown.The date received by manufacturer was entered into the date of event field.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.

• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50914946
• Report Number: 2020394-2026-02888
• Device Sequence Number: 17478935
• Product Code: KNW
• UDI-Device Identifier: 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 12/31/2025
• Device Catalogue Number: MG1522
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• 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