MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM 20 MM CUE LINEAR SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770603

Device Problem Poor Quality Image (1408)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been received by the manufacturer for evaluation. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

Per tm - mentioned poor image quality.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 20 MM CUE LINEAR
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11027345
• MDR Text Key: 222761590
• Report Number: 3006260740-2020-20981
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K182281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9770603
• Device Catalogue Number: 9770603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 12/17/2020 Patient Sequence Number: 1