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); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
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 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.
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly fired without pressing the trigger.There was no reported patient injury.
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 bip biomedizinische intstrumente und produkte gmbh.The magnum driver was visually inspected upon receipt and was found to be normal condition.The screw hole for the m3x12 screw in the rear end of the main body which holds the rear body sub assembly and the main body in place is damaged and the screw can not be tight end and main body is bend and cover indicator spring broken.The device was functionally tested and failed the tests due to leaf spring for the stylet sled is bend and did activate the trigger identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the reported device fire without pressing trigger issue and the investigation is determined to be confirmed for the identified damaged screw hole for the m3x12 screw in the rear end of the main body and broken cover indicator spring issue and the investigation is determined to be confirmed for the identified main body bend issue.The root cause for reported device fire without pressing trigger issue was determined to be leaf spring for the stylet sled is bend and did activate the trigger identified during evaluation.The root cause for identified damaged screw hole for the m3x12 screw in the rear end of the main body issue could not be determined based on the provided information.The root cause for identified main body bend issue could not be determined based on the provided information.The root cause for identified broken cover indicator spring 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 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 during a biopsy procedure, the device allegedly fired without pressing the trigger.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: 20730541
• Report Number: 2020394-2024-01717
• Device Sequence Number: 8396037
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 12/23/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/21/2025
• 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