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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS SITE-RITE PREVUE PLUS SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 9770086
Device Problems Poor Quality Image (1408); Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported by the clinician that the picture quality is grainy and isn¿t clear when free gel is used on prevue plus system as opposed to the image quality when gel caps are used on the units. This causes an issue when imaging for tiny veins on pediatric patients. The vascular access team uses free gel on the prevue units as well but they do not see the same issues with image quality. No patient injury reported.
 
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Brand NameSITE-RITE PREVUE PLUS
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
teresa johnson
605 n. 5600 w.
salt lake city, UT 84116
8015225435
MDR Report Key7170221
MDR Text Key96665662
Report Number3006260740-2018-00003
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 01/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9770086
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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? Yes
Type of Device Usage Reuse

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