MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REFURBISHED, SITE~RITE VISION II TOWER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770177R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.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.Customer declined returning equipment for evaluation.
Event or Problem Description
Sales rep reported: the system shuts down multiple times per picc placement.

• Brand Name: REFURBISHED, SITE~RITE VISION II TOWER
• 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: 8494117
• Report Number: 3006260740-2019-00817
• Device Sequence Number: 1253502
• Product Code: IYN
• UDI-Device Identifier: 00801741125362
• UDI-Public: (01)00801741125362
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K132942
• 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): 04/08/2019

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: 9770177R
• Device Catalogue Number: 9770177R
• 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: 03/19/2019
• Initial Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1