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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 3941641
Device Problems Connection Problem (2900); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 06/23/2020
Event Type  malfunction  
Event Description
Patient required iv access upon admission. Using the new smiths medical jelco viavalve safety iv catheters, it took four nurses and six attempts to successfully obtain iv access. Because it took so many attempts, the golden hour was not met and there was a delay in starting iv fluids and administering medications. These new iv catheters are extremely difficult to use, often requiring two sets of hands to remove the catheter from the needle and attach the t-connector. Even if the iv catheter is inserted into the vein correctly, it is difficult to keep the catheter stable enough to remove it from the needle without losing access. Learning specialist met with cns (clinical nurse specialist) and company to discuss issues with current iv catheters.
 
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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 Key12066001
MDR Text Key258350653
Report Number12066001
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
Device Lot Number3941641
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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