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

Catalog Number	MN1825
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.H11: section a through f - the information provided by bd represents all of 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 an ultrasound guided biopsy through normal density issue, the needle's gauge allegedly became loose from the metal part.A coaxial was used and the procedure was completed with another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an ultrasound guided biopsy through normal density issue, the needle's gauge allegedly became loose from the metal part.A coaxial was used and the procedure was completed with another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one electronic video was received and reviewed.The video shows the magnum needle, and the cannula hub was noted to be separated from the cannula.Based on the video review, the reported detachment of device issue can be confirmed.Received one magnum biopsy needle.Product packaging and label were returned, and product information was verified with tw.The magnum biopsy needle was received with protective tubing.The magnum biopsy needle appeared to have blood residue throughout the cannula.Upon visual evaluation, the cannula hub was noted to be separated from the proximal end of the cannula.The cannula was inspected, and the sandblasting was noted to be homogeneous.The proximal end of the cannula was noted to be flared outwards.Due to the nature of the complaint, functional testing was not performed.Therefore, the investigation is confirmed for the reported event as the cannula hub was noted to be detached from the cannula.A definitive root cause for the alleged detachment of device or device component issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3 h11: e1, h6 (method, result, conclusion) 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.

• Brand Name: MAGNUM NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21010696
• Report Number: 2020394-2024-01881
• Device Sequence Number: 8329241
• Product Code: FCG
• UDI-Device Identifier: 00801741084362
• UDI-Public: (01)00801741084362(11)230721(17)260531(10)REHT3625
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K934370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: 05/31/2026
• Device Catalogue Number: MN1825
• Device Lot Number: REHT3625
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 12/24/2024
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 105 KG