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

Catalog Number	1810MS
Medical Device Problem Codes	Break (1069); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a biopsy procedure, a plastic allegedly comes out from the inside of the product.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot 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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2026).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 a biopsy procedure, a plastic allegedly comes out from the inside of the product.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: two electronic photo was provided and reviewed.Both photo shows that, a plastic like material which was shown.Based on the photo review, the reported foreign material cannot be confirmed.Received one mission disposable core biopsy instrument, one compatible coaxial needle, two needle protectors, and one gauze pad.Product packaging and label were returned, and product information was verified with tw.During visual evaluation, one protective tubing appeared to be missing a portion of plastic material in the center.A gauze pad was received containing what appeared to be a piece of plastic in the center.No other anomalies were noted.On functional testing, the plastic fragment was examined under the microscope under 30x magnification.The fragment is consistent with the shape of missing material from the needle tip protector.One end of the plastic fragment has some twisted material that is consistent with twisted plastic material on the inside of the needle tip protector adjacent to the missing portion.The other end of the fragment tapers down to a point which is also consistent with another end of the missing portion of the needle tip protector.The needle tip protector was cut, and the plastic fragment almost exactly aligns within the missing portion of the needle tip protector.Exact fit could not be obtained due to the twisting of the plastic both on the fragment and inside of the needle tip protector.Therefore, the investigation is unconfirmed for the reported device contamination with chemical or other material as it is apparent that the piece reported is from the needle protector.Also, the investigation is identified and confirmed for the break as the cause will remain unknown.A definitive root cause for the reported device contamination with chemical or other material and identified break 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, h6 (device, method).H11: d4 (unique identifier (udi) #), h6 (result, conclusion).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.

• 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: 20075251
• Report Number: 2020394-2024-01302
• Device Sequence Number: 14211921
• Product Code: KNW
• UDI-Device Identifier: 00801741096983
• UDI-Public: (01)00801741096983(11)231118(17)260828(10)0001532313
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/24/2025

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: 08/28/2026
• Device Catalogue Number: 1810MS
• Device Lot Number: 0001532313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2023
• 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: Unknown