MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 6 PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number	9770001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.Device has not been returned, at this time.
Event or Problem Description
Per biomed: site rite 6 probe 10145405 is causing some blank spots, artifact in the image.Possible damaged crystals in the probe.

• Brand Name: SITE~RITE 6 PROBE
• 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: 7340080
• Report Number: 3006260740-2018-00437
• Device Sequence Number: 84255
• Product Code: IYO
• UDI-Device Identifier: 00801741125744
• UDI-Public: (01)00801741125744
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K071204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

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: 9770001
• 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: Not provided
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1