MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REFURB, SITE-RITE PREVUE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770090R
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received by the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Per vat: the prevue will not charge.Ac adapter has been changed but made no difference.This machine is used almost daily in our facility to assist with new and difficult cannulations.Since it stopped charging on (b)(6) 2019 there has been an increase in multiple cannulations and infiltrations of new fistulas.Some patients are even having cannulations held due to the complexities of their arms with no ultrasound assist to map them.This is leading to longer time with a catheter.

• Brand Name: REFURB, SITE-RITE PREVUE
• 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: 8446381
• Report Number: 3006260740-2019-00653
• Device Sequence Number: 2818946
• Product Code: IYO
• UDI-Device Identifier: 00801741124938
• UDI-Public: (01)00801741124938
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K150529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

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: 9770090R
• Device Catalogue Number: 9770090R
• 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: 02/28/2019
• Initial Report FDA Received Date: 03/22/2019
• 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: Hospitalization