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

Model Number	1610MS
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	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.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.(expiration date: 06/2025).Device pending return.
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy through normal density tissue, the needle allegedly bent.Reportedly, the needle was pulled out by force.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 this product is bd-santo domingo.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 disposable core biopsy instrument was received for evaluation.Upon visual evaluation the device appeared to have residue throughout the cannula and the sample notch.The sample notch was noted to be bent forward.No other visual anomalies were noted to the device.Functional testing was not performed, due to the nature of the complaint.Therefore, the investigation for the reported needle bent is confirmed as the needle bent was noted in the physical evaluation.However, the reported difficult to remove remains inconclusive as the condition of use could not be replicated.A definitive root cause for the alleged needle bent and difficult to remove could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 06/2025), g3.H11: h6 (method, 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.H3 other text : see h10.
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy through normal density tissue, the needle allegedly bent.Reportedly the needle was pulled out by force.No coaxial was used and the procedure was completed using another device.There was no reported patient injury.

• Brand Name: MISSION
• 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: 16589137
• Report Number: 2020394-2023-00184
• Device Sequence Number: 12278913
• Product Code: KNW
• UDI-Device Identifier: 00801741096969
• UDI-Public: (01)00801741096969
• 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): 04/21/2023

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 Model Number: 1610MS
• Device Catalogue Number: 1610MS
• Device Lot Number: 0001478980
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2022
• 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