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

Catalog Number	MG1522
Medical Device Problem Codes	Break (1069); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a biopsy procedure, the prime indicator was allegedly detached, and the needle placed in the gun was allegedly fired on its own.There was no patient contact.
Additional Manufacturer Narrative
H10: 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 serial number (b)(6) was received at the novatecnica.The magnum driver was visually inspected upon receipt the red position indicator is missing and there is damage to the lower part of the position indicator.No further damage to the equipment is evident.The device was functionally tested and failed the tests due to wear in springs which could generate the triggering of the magnum identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the reported priming indicator off issue and the investigation is determined to be confirmed for the reported fired on its own issue.The root cause for reported priming indicator off issue could not be determined based on the provided information.It may be likely due to the wear of the part and the vibration of the equipment at the time of downloading detached it.The root cause for reported fired on its own issue was determined to be wear in springs which could generate the triggering of the magnum identified during evaluation.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.H11: 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
It was reported that prior to a biopsy procedure, the prime indicator was allegedly detached, and the needle was placed in the gun, and it allegedly fired on its own.There was no patient contact.
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 return of the sample is pending.The investigation of the reported event is currently underway.H11: 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.

• 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: 21024777
• Report Number: 2020394-2024-01905
• Device Sequence Number: 21100565
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945(17)250630(10)VTES0192
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 02/10/2025

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: 06/30/2025
• Device Catalogue Number: MG1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/21/2025
• 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