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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 Problem Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.Results are expected soon.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 no other similar product complaint(s) from this serial number.
 
Event Description
Per tm: the system's screen keeps jumping all over the place.
 
Manufacturer Narrative
The information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of system screen keeps jumping all over the place was unconfirmed.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to refurbished inventory.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 no other similar product complaint(s) from this serial number.
 
Event Description
Per tm: the systems screen keeps jumping all over the place.
 
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Brand Name
SITE-RITE PREVUE PLUS
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8298110
MDR Text Key134866582
Report Number3006260740-2019-00157
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741125072
UDI-Public(01)00801741125072
Combination Product (y/n)N
PMA/PMN Number
K120882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9770086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Event Location Hospital
Date Manufacturer Received03/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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