MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Magnum; 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	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent reusable biopsy procedure using magnum.It was reported that the magnum driver prematurely fires during cocking.There was no patient involvement reported.
Event or Problem Description
A patient was scheduled to undergo a biopsy procedure using a magnum reusable biopsy instrument.It was reported that the magnum driver fired prematurely during the cocking process.There was no reported patient involvement.
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 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.
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 found in normal condition.The cocking slide, cannula sled, stylet sled are 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 prematurely fires during cocking issue and the investigation is determined to be confirmed for the identified cocking slide, cannula sled, stylet sled are worn out issue.The root cause for reported prematurely fires during cocking issue cannot be determined as the problem could not be reproduced.The root cause for identified cocking slide, cannula sled, stylet sled are worn out issue could not be determined based on the provided information.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labelling, packaging, or use related issue.B3.The date received by manufacturer has been used for this field.G3, h6 (device, component, method, 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.

• Brand Name: Magnum
• 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: 50446982
• Report Number: 2020394-2026-02236
• Device Sequence Number: 10486902
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945(17)260331
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 09/22/2026

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: 03/31/2026
• Device Catalogue Number: MG1522
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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