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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REFURB, SITE-RITE 8; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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BARD ACCESS SYSTEMS REFURB, SITE-RITE 8; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 9770500R
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device has not been received by the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.Device has not been received, at this time.
 
Event Description
Machine is frozen.
 
Manufacturer Narrative
H11:section a through f - 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 initial complaint appeared to be a reportable occurrence.Upon further review it was determined that a reportable event had not occurred.Therefore, this event is deemed not reportable per 21 cfr part 803.
 
Event Description
Machine is frozen.
 
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Brand Name
REFURB, SITE-RITE 8
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 Key9528377
MDR Text Key178354080
Report Number3006260740-2019-04028
Device Sequence Number1
Product Code IYO
UDI-Device Identifier10801741104128
UDI-Public(01)10801741104128
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9770500R
Device Lot NumberN/A
Was Device Available for Evaluation? No
Event Location Hospital
Date Manufacturer Received01/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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