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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REFURB, SITE-RITE PREVUE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS REFURB, SITE-RITE PREVUE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number N/A
Device Problem Poor Quality Image (1408)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, 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 complaint of poor image quality was reproduced and confirmed by the service facility during evaluation. The returned prevue sustained damaged to the front and back enclosures, probe entry cover, and the probe. The cause of the intermittent poor image quality was identified to be the probe damage. All damage found on the unit appear to be use-related damage, possibly resulting from dropping the unit as the customer reported. The manufacture site reported that the scanner passed functional testing requirements prior to shipment to this customer. Manufacturing records were reviewed and no potential contributing factors were found during manufacture and quality inspection of the device. A history review of serial number dyxie054 showed no other similar complaint(s) from this serial number.
 
Event Description
It was reported that the prevue unit looked to have been dropped a few times. The users are also reporting that the unit has poor image quality and they are having a hard time seeing the needle tip.
 
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 has not been returned.
 
Event Description
It was reported that the prevue unit looked to have been dropped a few times. The users are also reporting that the unit has poor image quality and they are having a hard time seeing the needle tip.
 
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Brand NameREFURB, SITE-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. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer Contact
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key7232811
MDR Text Key195804105
Report Number3006260740-2018-00073
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741124938
UDI-Public(01)00801741124938
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150529
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number9770090R
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received06/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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