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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIAVALVE SAFETY IV CATHETER-RADIOPAQUE 22G X 1 IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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VIAVALVE SAFETY IV CATHETER-RADIOPAQUE 22G X 1 IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 10
Device Problem Leak/Splash (1354)
Patient Problem Bruise/Contusion (1754)
Event Date 10/12/2021
Event Type  malfunction  
Event Description
Iv inserted without difficulty, was found to be leaking blood at the insertion site, pressure was held at the site, but continued to leak blood, iv was flushing well without infiltration. Iv was discontinued, catheter was noted to be intact. Upon further inspection of the hub and catheter it was found to have a leak at the connection between the catheter and the blue iv hub. Patient was found to have some bruising surrounding insertion site due to leaking during brief period the iv was in place. Pressure was held and hemostasis was achieved, gauze and bandaid in place. Fda safety report id # (b)(4).
 
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Brand NameVIAVALVE SAFETY IV CATHETER-RADIOPAQUE 22G X 1 IN
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12711592
MDR Text Key279258692
Report NumberMW5105005
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10
Device Lot Number4160896
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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