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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770500
Device Problem Poor Quality Image (1408)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard 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 bard. The device has not been returned to the manufacturer for evaluation. 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 one other similar product complaint(s) from this serial number. Device not returned for evaluation.
 
Event Description
Sales rep reported on behalf of clinical coordinator that site rite 8 ultrasound system (9770500) image is fuzzy. It was stated there isn¿t anything wrong with the probe that is visible.
 
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Brand NameSITE-RITE 8 ULTRASOUND
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7857368
MDR Text Key119799448
Report Number3006260740-2018-02407
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770500
Device Catalogue Number9770500
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
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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