MAUDE Adverse Event Report: ICUMEDICAL EXTENSION SET; TUBING, FLUID DELIVERY

Model Number SF3258-15H

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 03/28/2018

Event Type  Injury  

Event Description

Nurse infusing ivig and spiked the bottle with secondary tubing.When nurse vented the tubing, medication began to leak out of the vent hole.

• Brand Name: EXTENSION SET
• Type of Device: TUBING, FLUID DELIVERY
• Manufacturer (Section D): ICUMEDICAL; san clemente CA 92673
• MDR Report Key: 7398797
• MDR Text Key: 104563050
• Report Number: MW5076323
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: SF3258-15H
• Device Lot Number: 3610742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention