MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE VISION II 20MM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770169
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.Results are expected soon.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 biomed: the ultrasound scans are too dark.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample(if available), applicable fmea documents, labeling and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of ultrasound scans are too dark was unconfirmed.During inspection the probe was tested and worked normally, no root cause confirmation since the issue could not be reproduced.The device was discarded due to being discontinued product.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 biomed: the ultrasound scans are too dark.

• Brand Name: SITE-RITE VISION II 20MM
• 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: 8092453
• Report Number: 3006260740-2018-03333
• Device Sequence Number: 2792327
• Product Code: ITX
• UDI-Device Identifier: 00801741125348
• UDI-Public: (01)00801741125348
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K132942
• 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,Followup
• Report Date (Section B): 08/30/2019

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: 9770169
• Device Catalogue Number: 9770169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1