• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Positioning Problem (3009)
Patient Problem No Code Available (3191)
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, at this time, for evaluation. A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number. Device not returned.
 
Event Description
Rn reported ultrasound doesn't seem to be accurate when they use it to place ivs and wanted to know if it needed to be calibrated. Rn stated that they either go too far or not far enough with referencing the ultrasound. Rn advised they are seeing the dimpling and vein bouncing back in the ultrasound image, but are not seeing flashback. Patients end up needing multiple needle sticks during procedures, resulting in procedural delay, due to difficulty in visualizing the vein.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
sydney freckleton
605 n. 5600 w.
salt lake city, UT 84116
8015225992
MDR Report Key7642791
MDR Text Key112565154
Report Number3006260740-2018-01499
Device Sequence Number1
Product Code ITX
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 06/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770501
Device Catalogue Number9770501
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

-
-