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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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SMITHS MEDICAL ASD, INC. JELCO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number 3846389
Device Problem Product Quality Problem (1506)
Patient Problems Extravasation (1842); Pain (1994)
Event Date 06/24/2020
Event Type  malfunction  
Event Description
Infant requiring new iv placement. Veins plentiful and very visible. Level 2 charge nurse attempted iv x2 with smith medical jelco 24g x 5/8" viavalve safety iv catheter lot #3846389 and vein blew before t-connector was even applied. Level 3 doctor/transport rn was called to start iv. Using same type of catheter, 3 veins also blew prior to t-connector being placed. On first attempt with the insyte-n autoguard 24 g x 0. 56in lot #9277846 iv was placed without complications. There has been an increase in problems with the new iv catheters in the nicu patients. We will continue to monitor and track problems with the new iv catheters.
 
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Brand NameJELCO
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 Key12065916
MDR Text Key258365767
Report Number12065916
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 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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