MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRA MARKER; BIOPSY INSTRUMENT

Model Number	SMMA11R
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported one malfunctions, lot number was provided and the manufacturing review was performed.The device was returned for evaluation.The investigation is confirmed for the alleged failure to deploy and detachment of device component the definitive root cause could not be determined based upon the available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model smma11r biopsy instrument stent allegedly failed to deploy and detachment of device component.The information was received from a single source.One patient was involved with no reported patient injury.A female patient's age and weight was not provided.

• Brand Name: SENOMARK ULTRA MARKER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10280378
• Report Number: 2020394-2020-04470
• Device Sequence Number: 14085030
• Product Code: NEU
• UDI-Device Identifier: 00801741032073
• UDI-Public: (01)00801741032073
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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: No Information
• Device Model Number: SMMA11R
• Device Catalogue Number: SMMA11R
• Device Lot Number: VTCP00083
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/15/2020
• Patient Sequence Number: 1