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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
Lot Number 3846389
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Needle Stick/Puncture (2462)
Event Date 06/22/2020
Event Type  malfunction  
Event Description
Baby stuck 5 times with new jelco 24g 5/8" iv catheters in optimal looking veins by peripheral intravenous (piv) placement expert rns. Blood return visualized, trouble advancing catheter in vein, which eventually blew the vein. New iv catheters not conducive for ease of use in babies, making the baby susceptible to multiple piv sticks and delaying treatment and care. Golden hour was not met, as piv access was not obtained in time. Iv fluids were started at after 1 hour and 30 minutes of admission. Father was at bedside the entire time and witnessed the process. Educator met with clinical nurse specialist (cns) and company to discuss issues with catheters. Jelco catheter. Smiths medical jelco 24g 5/8".
 
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Brand NameJELCO VIAVALVE
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key12066025
MDR Text Key258366117
Report Number12066025
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 06/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number3846389
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2021
Event Location Hospital
Date Report to Manufacturer06/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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