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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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BARD ACCESS SYSTEMS SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Catalog Number 9763000
Device Problem Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
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
It was reported that the display image is blurred.
 
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Brand NameSITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
DYMAX CORP.
141 zehner school road
zelienople PA 16063
Manufacturer Contact
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key9992866
MDR Text Key188736181
Report Number3006260740-2020-01510
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K052517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9763000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/01/2019
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

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