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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM 20 MM CUE LINEAR SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM 20 MM CUE LINEAR SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
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.
 
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Brand NameSITE~RITE 8 ULTRASOUND SYSTEM 20 MM CUE LINEAR
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key11027345
MDR Text Key222761590
Report Number3006260740-2020-20981
Device Sequence Number1
Product Code ITX
UDI-Device Identifier00801741138218
UDI-Public(01)00801741138218
Combination Product (y/n)N
PMA/PMN Number
K182281
Number of Events Reported1
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 Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770603
Device Catalogue Number9770603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
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
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