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

Model Number 9770169

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

Per biomed: the ultrasound scans are too dark.

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 Description

Per biomed: the ultrasound scans are too dark.

• Brand Name: SITE-RITE VISION II 20MM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8092453
• MDR Text Key: 128078515
• Report Number: 3006260740-2018-03333
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741125348
• UDI-Public: (01)00801741125348
• Combination Product (y/n): N
• PMA/PMN Number: K132942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1