MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MAGNUM INSTRUMENT; 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	09/04/2024
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.H10: d4 (expiration date: 12/2050).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 prior to a biopsy procedure, the device allegedly unable to lock when the needle was inserted and had fired off without intent.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 51gv0087 was received at the bip biomedizinische intstrumente und produkte gmbh.The magnum driver was visually inspected upon receipt and was found to be in normal condition.Also identified, cocking slide, cannula, stylet sled and sled position indicator are worn out.The device was functionally tested and passed the test during device evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported fired off without intent issue and the investigation is determined to be confirmed for the identified cocking slide, cannula and stylet sled are worn out.The root cause for reported fired off without intent issue cannot be determined as the problem could not be reproduced.The root cause for identified cocking slide, cannula and stylet sled are worn out 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.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 prior to a biopsy procedure, the device allegedly unable to lock when the needle was inserted and had fired off without intent.There was no patient contact.

• 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: 20342661
• Report Number: 2020394-2024-01519
• Device Sequence Number: 7842198
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 11/21/2024

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: 09/04/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 12/04/2024
• 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