MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; CATHETER, IV

Lot Number 3491237

Device Problem Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Date 06/20/2018

Event Type  malfunction  

Event Description

The nicu staff is reporting multiple problems with the smiths medical jelco 24g 5/8" protect iv catheter.Over the last several months the staff reports that among a healthcare team that performs peripheral vascular access on neonatal patients the staff has had repeated problems with the catheter not exhibiting a flash back of blood, including those that are performed with the assistance of a venous illuminator, where venous access can be validated.The problem has created multiple iv access attempts on a very vulnerable patient population and even those infants that are full term with easily accessible access.The educational staff worked with the staff to assist with any technique issues but the problem has been reoccurring.The department is now trialing a catheter from a different manufacturer.Nicu and materials management contacted smiths medical and the product surveillance department.The surveillance team asked for additional information in order to further investigate by members of their quality team.

• Brand Name: JELCO
• Type of Device: CATHETER, IV
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7673257
• MDR Text Key: 113528297
• Report Number: 7673257
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3491237
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1