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

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.

• Brand Name: JELCO
• 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 Key: 12065916
• MDR Text Key: 258365767
• Report Number: 12065916
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3846389
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1