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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM W/PINPOINT GT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM W/PINPOINT GT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770501
Device Problem Moisture Damage (1405)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will be evaluated. Results are expected soon. A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number. 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.
 
Event Description
Picc team nurse reported that site rite 8 ultrasound with pinpoint gt has moisture damage behind the screen causing the system to have a foggy image. Pictures of ultrasounds attached to record.
 
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Brand NameSITE~RITE 8 ULTRASOUND SYSTEM W/PINPOINT GT
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
kizi zaccaria
605 n. 5600 w.
salt lake city, UT 84116
8015225594
MDR Report Key7768337
MDR Text Key116912425
Report Number3006260740-2018-01998
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770501
Device Catalogue Number9770501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/12/2019
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

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