MAUDE Adverse Event Report: ICU MEDICAL, INC. INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number SF3258-15H

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 04/11/2018

Event Type  Injury  

Event Description

Nurse was infusing medication to a patient from a glass bottle which requires the secondary line to be vented.After the nurse opened the vent on the secondary line and began the infusion, the medication began leaking out of the vent.The infusion was stopped and new line was hung.The patient lost some of the dose of medication as a result of the defect in the tubing.

• Brand Name: INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC. ; san clemente CA 92673
• MDR Report Key: 7446808
• MDR Text Key: 106204887
• Report Number: MW5076601
• Device Sequence Number: 1
• Product Code: FPA
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• 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