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

Catalog Number	MG1522
Medical Device Problem Codes	Failure to Prime (1492); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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.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 the magnum device fires when in first charge and it fires well but the second one fires by itself.There is no patient involvement.Additional information received, the device primed and locked into the first prime position then when they were priming the second time the device primed and locked into full prime position then fired immediately after it was fully primed.
Event or Problem Description
It was reported that the magnum device fires when in first charge and it fires well but the second one fires by itself.There is no patient involvement.Additional information received, the device primed and locked into the first prime position then when they were priming the second time the device primed and locked into full prime position then fired immediately after it was fully primed.
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 bad condition.The device was functionally tested and failed the tests due to device has sometimes problems to hold the sleds in place because the device is so dirty that the sequencer can not work right identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be inconclusive for the reported device self-activation issue, and the investigation is determined to be confirmed for the identified device has sometimes problems to hold the sleds in place issue.The root cause cannot be determined as the device could not be tested for the reported device self activation issue.The root cause for identified device has sometimes problems to hold the sleds in place issue was determined to be dirt in device which cause sequencer cannot work right 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.G3, h6 (device, component, 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: 22392168
• Report Number: 2020394-2025-00961
• Device Sequence Number: 9104652
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945(17)231130
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 08/19/2025

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: 11/30/2023
• Device Catalogue Number: MG1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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