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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC JELCO VIAVALVE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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SMITHS MEDICAL ASD INC JELCO VIAVALVE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 12/31/2020
Event Type  malfunction  
Event Description
Patient required 8 iv attempts by 4 experienced rns.Smiths medical iv catheters were used and some of the catheters seemed to not be able to pierce the skin and other catheters were difficult to remove from the hub causing the iv to move and dislodge from its position.After 7 unsuccessful attempts with the smith medical catheters, a bd catheter (previous brand) was found and used resulting in a successful iv placement.Iv catheters difficult to use in the neonatal population despite adequate training.Excessive sticks for infant.Have spoken to materials management to return previously used catheters for the neonatal population.System wide we converted from protect iv to smiths medical iv catheters in 2019 with the exception of nicu, which we converted shortly after.I will follow up with value analysis team as we in central have not been notified to convert any of the iv catheters.
 
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Brand Name
JELCO VIAVALVE
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD INC
6000 nathan lane north
minneapolis MN 55442
MDR Report Key12127280
MDR Text Key260280624
Report Number12127280
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2021
Event Location Hospital
Date Report to Manufacturer07/07/2021
Type of Device Usage Unknown
Patient Sequence Number1
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