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

Catalog Number	MG1522
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Self-Activation or Keying (1557); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.H11: section a through f - the information provided by bd represents all of 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 prior to a biopsy procedure, the device triggers when wound up.Additional information received that a bard needle installed when the magnum device fired on its own prior to a procedure.There was no patient involvement.
Event or Problem Description
It was reported that prior to a biopsy procedure, the magnum driver triggers when wound up.Additional information received that a bard needle was installed when the magnum driver fired on its own prior to a procedure.There was no patient involvement.
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 bip biomedizinische intstrumente und produkte gmbh.The magnum driver was visually inspected upon receipt and was found to be in a normal condition.Rear body is worn out.The device was functionally tested and failed stylet sled force test identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device triggers when wound up issue, the investigation is determined to be confirmed for the identified rear body is worn out issue and the investigation is determined to be confirmed for the identified stylet sled force test failed issue.The root cause for reported device triggers when wound up issue cannot be determined as the problem could not be reproduced.The root cause for identified rear body is worn out issue could not be determined based on the provided information.The root cause for identified stylet sled force test failed issue could not be determined based on the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, e1, g2, 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 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: 21880341
• Report Number: 2020394-2025-00597
• Device Sequence Number: 8640895
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945(17)260731
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K934371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 07/31/2026
• Device Catalogue Number: MG1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 08/13/2025
• 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