MAUDE Adverse Event Report: BARD ACCESS SYSTEMS L-VA VASCULAR ACCESS PROBE FOR SITE~RITE V; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number	9760034
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned, at this time.
Event or Problem Description
It was reported that there are image flickers on the screen.

• Brand Name: L-VA VASCULAR ACCESS PROBE FOR SITE~RITE V
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8092454
• Report Number: 3006260740-2018-03334
• Device Sequence Number: 19336762
• Product Code: ITX
• UDI-Device Identifier: 00801741125720
• UDI-Public: (01)00801741125720
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K052517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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 Catalogue Number: 9760034
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1