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

Model Number	2016MSK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient prone, and localizer needle placed for right lung biopsy.During second pass of biopsy, the introducer needle plastic tip came off the needle.Leaving the needle behind in the patient, and the plastic tip in the radiologists hand.Biopsy was terminated at this point.Placement needle was removed, introducer needle stayed in patient.Was pulled out seperate, and additional images showed no needle inside patient.

• Brand Name: MISSION
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st; tempe AZ 85281
• MDR Report Key: 20693746
• Report Number: 20693746
• Device Sequence Number: 8700924
• Product Code: KNW
• UDI-Device Identifier: 00801741097096
• UDI-Public: (01)00801741097096
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/11/2024
• Report Date (Section F): 09/11/2024

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 Model Number: 2016MSK
• Device Catalogue Number: 2016MSK
• Device Lot Number: (10)0001564792
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Date Report Sent to FDA: 09/11/2024