• 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 PREVUE 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 PREVUE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770090
Device Problem No Display/Image (1183)
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 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.
 
Event Description
Sales rep reported half of the screen remains black.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSITE-RITE PREVUE
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.
141 zehner school road
zelienople PA 16063
Manufacturer Contact
kizi zaccaria
605 n. 5600 w.
salt lake city, UT 84116
8015225594
MDR Report Key7768183
MDR Text Key116902393
Report Number3006260740-2018-01982
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741091056
UDI-Public(01)00801741091056
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2019
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 Number9770090
Device Catalogue Number9770090
Device Lot NumberN/I
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date07/18/2018
Event Location Hospital
Date Manufacturer Received05/01/2019
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

-
-