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

Catalog Number	MN1820
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ultrasound-guided prostate biopsy procedure, the needle notch allegedly had foreign material.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2025) 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.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one bard magnum biopsy needle was returned for evaluation.On visual evaluation, the sample appeared to have residue on the cannula and at the distal end of stylet.And it was noted that the foreign material was returned with this sample and the wire like material came back with the device.And ftir analysis was done, it was noted that the eds analysis showed the major peak of titanium (ti) and minor peaks of aluminum(al) and vanadium(v).One electronic photo was provided for review.Photo shows the wire like material where the wire was noted to be damaged.Therefore, based on the photo review, the reported failure foreign material can be confirmed.Based on the photo review and sample evaluation analysis, the reported foreign material is confirmed as the wire like material was noted along the package.A definitive root cause for the alleged device contamination with chemical or other material 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: b5, d4 (expiry date: 10/2025), g3, h6 (method).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 prostate biopsy procedure, a foreign material was allegedly found on the needle notch of the device.There was no reported patient injury.

• 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: 17377042
• Report Number: 2020394-2023-00532
• Device Sequence Number: 17801835
• Product Code: FCG
• UDI-Device Identifier: 00801741084355
• UDI-Public: (01)00801741084355
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 10/26/2023

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: MN1820
• Device Lot Number: REGZ0318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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