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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 PINPOINT GT PROBE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT PROBE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770602Y
Device Problem Poor Quality Image (1408)
Patient Problem Insufficient Information (4580)
Event Date 12/31/2020
Event Type  malfunction  
Manufacturer Narrative
The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd. 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. Device not returned for evaluation.
 
Event Description
Per biomed - poor image quality.
 
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Brand NameSITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT PROBE
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 Key11208992
MDR Text Key229303871
Report Number3006260740-2020-21408
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 12/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770602Y
Device Catalogue Number9770602Y
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/21/2021 Patient Sequence Number: 1
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