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

Catalog Number	1410MS
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	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy procedure through normal tissue, the needle allegedly bent while penetrating during a breast biopsy and the cutting didn't go all the way.It was further reported that the needle was allegedly difficult to be removed from the breast.No coaxial was used and the procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.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.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2024) 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.H3 other text : device pending return.
Additional Manufacturer Narrative
The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: received one mission disposable core biopsy instrument for evaluation.During visual evaluation, the device appeared to have residue throughout and the device was returned in initial configuration.It was noted that there was a slight bent to the needle.Further, functional testing was not performed due to the condition the sample was received in.Therefore, the investigation is confirmed for reported material twisted/bent issue as the slight bent was noted to the needle.And, the investigation is inconclusive for the reported difficult to remove issue as the use of condition cannot be replicated in the laboratory.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: d4 (expiry date: 08/2024), g3 h11: h6 (method, 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.
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy procedure through normal tissue, the needle allegedly bent while penetrating during a breast biopsy and the cutting didn't go all the way.It was further reported that the needle was allegedly difficult to be removed from the breast.No coaxial was used and the procedure was completed using 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): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17698103
• Report Number: 2020394-2023-00660
• Device Sequence Number: 6631884
• Product Code: KNW
• UDI-Device Identifier: 00801741096945
• UDI-Public: (01)00801741096945
• 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): 11/17/2023

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: 1410MS
• Device Lot Number: 0001431586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/13/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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