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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT PROBE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT PROBE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770602Y
Device Problems Image Display Error/Artifact (1304); Poor Quality Image (1408)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.
 
Event Description
Per tm - there is a huge amount of raining interference in the image that cannot be removed with adjusting settings.
 
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 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 the probe is producing rain like image on the screen is confirmed.The root cause of the reported issue is an internal probe failure.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
 
Event Description
Per tm - there is a huge amount of raining interference in the image that cannot be removed with adjusting settings.
 
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Brand Name
SITE-RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT PROBE (REMANUFACTURED)
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 Key8877603
MDR Text Key154009228
Report Number3006260740-2019-02357
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741138201
UDI-Public(01)00801741138201
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/12/2020
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 Model Number9770602Y
Device Catalogue Number9770602Y
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2019
Event Location Hospital
Initial Date Manufacturer Received 07/18/2019
Initial Date FDA Received08/09/2019
Supplement Dates Manufacturer Received02/24/2020
Supplement Dates FDA Received03/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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