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

Model Number	1810MSK
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During ct guided liver biopsy the bard biopsy needle was inside the patient and bent while in the coaxial introducer.Needle was removed and new bard biopsy needle was used without incident.The provider insists there was no excessive force with needle was being used, and that this was a defective product.The result of previous bent needle required the patient's liver had to be re-biopsied creating a higher potential risk for bleeding post liver biopsy procedure.Manufacturer response for instrument, biopsy, bard® mission® (per site reporter): cr bard rep was given the bent needle.

• Brand Name: BARD® MISSION®
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 6968080
• Report Number: 6968080
• Device Sequence Number: 13726017
• Product Code: KNW
• UDI-Device Identifier: 00801741097058
• UDI-Public: (01)00801741097058
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017
• Report Date (Section F): 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/28/2020
• Device Model Number: 1810MSK
• Device Catalogue Number: 1810MSK
• Device Lot Number: HUBR1023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2017
• 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
• Patient Age: 56 YR
• Date Report Sent to FDA: 10/20/2017