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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SITE RITE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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BARD ACCESS SYSTEMS, INC. SITE RITE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 90013B01
Device Problem Unexpected Color (4055)
Patient Problem Insufficient Information (4580)
Event Date 01/13/2022
Event Type  malfunction  
Event Description
During picc placement, noticed that site rite needle guides were colored incorrectly.The 1.0 guide was dark green and should have been light green.Could not gain access into vein.Unsure if guide was just the wrong color of if the angle was that of the 1.5 guide instead of the 1.0.Site rite needle guide kit lot #refw4302.
 
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Brand Name
SITE RITE
Type of Device
TRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key13479651
MDR Text Key285231831
Report Number13479651
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/01/2022
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 Model Number90013B01
Device Catalogue NumberREFW4302
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2022
Event Location Hospital
Date Report to Manufacturer02/08/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/08/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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