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

Catalog Number	2010MS
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Fire (2610); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
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 return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 02/2025).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.
Event or Problem Description
It was reported that during a biopsy procedure, the resistance was allegedly not smooth when the needle was pulled out.It was further reported that after removing the needle, an iron wire was allegedly found inside.There was no reported patient injury.
Event or Problem Description
It was reported that during a biopsy procedure, the resistance was allegedly not smooth when the needle was pulled out.It was further reported that after removing the needle, an iron wire was allegedly found inside.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.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one mission biopsy device, trocar stylet, compatible coaxial, two blunt stylets, no depth stop and 10 mm adapter were received for evaluation.During visual evaluation, the device appeared to have residue throughout and the device was returned in initial configuration with the cannula at the 00 mm position.And also a wire-like material was returned with the device.Upon functional testing, an attempt to dry fire was unsuccessful as after the device was primed to 20mm and the plunger was depressed, then the device was disassembled to see if there was any material between the stylet and cannula however the stylet was unable to be removed from the cannula.Therefore, further functional testing cannot be performed.Also, one electronic photo was provided and reviewed.In that photo, a wire like material which was placed on a white paper was shown.Based on the photo review, the reported foreign material can be confirmed and reported difficult to remove cannot be confirmed.Therefore the investigation is confirmed for the reported foreign material as the wire like material were also returned for evaluation and the investigation is inconclusive for the reported difficult to remove due to the condition of the received device.The investigation is also confirmed for the identified failure to fire as received device was failed to fire during the dryfire test.A definitive root cause for the reported foreign material, reported difficult to remove and identified failure to fire 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: d4 (expiry date: 02/2025), g3, h6 (device).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: 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: 17468638
• Report Number: 2020394-2023-00562
• Device Sequence Number: 15326726
• Product Code: KNW
• UDI-Device Identifier: 00801741097027
• UDI-Public: (01)00801741097027
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 01/24/2024

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 Catalogue Number: 2010MS
• Device Lot Number: 0001455438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 01/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2022
• 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: Unknown