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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 6 SCANNER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS SITE~RITE 6 SCANNER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 9770066
Device Problem Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2018
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer, at this time, for evaluation.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
It was reported that there was a misalignment of the digital readout of the needle on the monitor in relation to the location of the needle and probe.
 
Event Description
It was reported that that there was a misalignment of the digital readout of the needle on the monitor in relation to the location of the needle and probe.
 
Manufacturer Narrative
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 scanner has been evaluated using the multipurpose vessel phantom and the test probe.The image was found to be normal for a site rite 6 with software 1.1.3 installed.The device was serviced, tested, and returned to the customer.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.
 
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Brand Name
SITE~RITE 6 SCANNER
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 Key8190882
MDR Text Key131334089
Report Number3006260740-2018-03739
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741091049
UDI-Public(01)00801741091049
Combination Product (y/n)N
PMA/PMN Number
K071204
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9770066
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Event Location Hospital
Initial Date Manufacturer Received 12/05/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received04/18/2019
Supplement Dates FDA Received05/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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