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

Catalog Number	1816MS
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
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 photo 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 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 lymph biopsy through normal density tissue, the needle was allegedly bent.It was further reported that the needle was allegedly difficult to be removed from the patient.No coaxial was used and the procedure was completed with another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One electronic photo was provided and reviewed.The photo shows one mission biopsy device within the package and the needle part was noted to be severely bent and also it shows label information which verifies and matches with trackwise.Based on the photo review, the reported needle bent issue can be confirmed and the reported difficult to remove cannot be confirmed.Therefore, the investigation is confirmed for the reported needle bent issue as the needle was noted to be severely bent on the provided photo and the investigation is inconclusive for the reported difficult to remove issue as no objective evidence was provided for review.A definitive root cause for the alleged needle bent and difficult to remove 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: b5, g3, h6 (method).H11: h6 (result, conclusion).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 during an ultrasound-guided lymph biopsy through normal density tissue, the cannula of the needle was allegedly bent.It was further reported that the needle was allegedly difficult to be removed from the patient.No coaxial was used and the procedure was completed with another device.There was no reported patient injury.

• Brand Name: MISSION NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CAREFUSION D.R. 203 LTD.; zona franca las americas; km 22-e-1; santo domingo 11606 ; DR 11606
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20597736
• Report Number: 2020394-2024-01655
• Device Sequence Number: 20472668
• Product Code: KNW
• UDI-Device Identifier: 00801741096990
• UDI-Public: (01)00801741096990(17)260428(10)0001515810
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171953
• 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): 12/21/2024

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 Expiration Date: 04/28/2026
• Device Catalogue Number: 1816MS
• Device Lot Number: 0001515810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 12/21/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown