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

Model Number	1610MS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy through normal density tissue, mission body allegedly broken while doing the surgery.There was another device used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.Two of photos were reviewed.Two photos show the outer retainer get detached from the device and the needle appeared bloody, no other specific anomalies noted.Therefore, based on the photo review, the reported break can be confirmed.A definitive root cause for the break could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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 not returned.
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy through normal density tissue, the mission body allegedly broken while doing the surgery.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: BARD MISSION DISPOSABLE CORE BIOPSY INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11019136
• Report Number: 2020394-2020-20854
• Device Sequence Number: 3822822
• Product Code: KNW
• UDI-Device Identifier: 00801741096969
• UDI-Public: (01)00801741096969
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: Other
• Device Model Number: 1610MS
• Device Catalogue Number: 1610MS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other