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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770602
Device Problems Defective Component (2292); Computer Operating System Problem (2898)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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
Per picc team and dm: probe froze during use.The picture was very dark despite changing settings.They also restarted the ultrasound, unplugged and plugged in again the probe without change.
 
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.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 site rite 8 was visually inspected upon receipt and was found to be in good physical condition.The probe is giving a poor image.The probe's image is rainy , there is no external damage on the probe.The probe is giving a poor image due to an internal failure of the probe.H3 other text : see h.11 for evaluation conclusion.
 
Event Description
Per picc team and dm: probe froze during use.The picture was very dark despite changing settings.They also restarted the ultrasound, unplugged and plugged in again the probe without change.
 
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Brand Name
SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
DYMAX CORP.
141 zehner school road
zelienople PA 16063
Manufacturer Contact
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key8927607
MDR Text Key155510822
Report Number3006260740-2019-02496
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741138324
UDI-Public(01)00801741138324
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/08/2022
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 Number9770602
Device Catalogue Number9770602
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 08/01/2019
Initial Date FDA Received08/23/2019
Supplement Dates Manufacturer Received08/01/2019
Supplement Dates FDA Received04/08/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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