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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC
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BARD ACCESS SYSTEMS SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Catalog Number 9763000
Device Problem Poor Quality Image (1408)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.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 the device was showing a black spot in the image not allowing to see the vessel.
 
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 poor image quality was unconfirmed.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
 
Event Description
It was reported that the device was showing a black spot in the image not allowing to see the vessel.
 
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Brand Name
SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER
Type of Device
TRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10489828
MDR Text Key205880660
Report Number3006260740-2020-03111
Device Sequence Number1
Product Code ITX
UDI-Device Identifier00801741091032
UDI-Public(01)00801741091032
Combination Product (y/n)N
PMA/PMN Number
K052517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9763000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2020
Event Location Hospital
Date Manufacturer Received02/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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