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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD INC. JELCO VIAVALVE SAFETY CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number 3962826
Device Problems Leak/Splash (1354); Connection Problem (2900)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/23/2020
Event Type  malfunction  
Event Description
Started iv on baby at 1030 using smith medical jelco 24g x 5/8 viavalve safety iv catheter. Able to obtain on 1st attempt, small bruise was noted at insertion site. Had some issues trying to screw on the baxter interlink system t- connector. Flushed well after iv secured. Needed to infuse 17 ml packed red blood cells (prbc). With only 1 hour left, a 1cm x 1cm spot of blood noted on bed. Tape wet with blood. Attempted to see if connection was loose, not loose, not leaking at site, not sure where was leaking, iv site was not infiltrated, could not flush or save iv site. Ended up pulling iv and having to restart another iv for 4ml prbc on a baby. Able to obtain the 2nd iv on 1st attempt, but the catheters are difficult to use, not easy to connect utilizing the smiths medical jelco iv cath with the baxter interlink system. Dealing with tiny babies, a better-quality iv catheter is needed along with a different t-connector, these tiny babies do not need multiple iv sticks. Educator met with clinical nurse specialist (cns) and company to discuss issues with catheters.
 
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Brand NameJELCO VIAVALVE SAFETY CATHETERS
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 Key12072105
MDR Text Key258709872
Report Number12072105
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 Number3962826
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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