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); Device Markings/Labelling Problem (2911); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
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 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 in normal condition.The sled position indicator faded and device markings unreadable on the rear body and the rear cover and both need to be updated.The device was functionally tested as device can be able to prime & fire.However, device failed the cover force test, cannula sled force test and stylet sled force test are out of specification identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device is jammed and wont fire, the investigation is determined to be confirmed for the identified sled position indicator faded, the investigation is determined to be confirmed for the identified cover force test, cannula sled force test and stylet sled force test are out of specification and the investigation is determined to be confirmed for the identified device markings unreadable on the rear body issue.The root cause for reported device is jammed and wont fire issue cannot be determined as the problem could not be reproduced.The root cause for identified sled position indicator faded issue could not be determined based on the provided information.The root cause for identified cover force test, cannula sled force test and stylet sled force test are out of specification issue could not be determined based on the provided information.The root cause for identified device markings unreadable on the rear body 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.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
A patient underwent a biopsy procedure using the magnum and it was reported that the device was jammed and wont fire.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: 22402469
• Report Number: 2020394-2025-00972
• Device Sequence Number: 8407580
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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 Catalogue Number: MG1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 07/04/2025
• 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