MAUDE Adverse Event Report: ICU MEDICAL, INC. HIGH PRESSURE 3-WAY, LUER-LOCK STOPCOCK; STOPCOCK, I.V. SET

Catalog Number 42353-01

Device Problem Fluid/Blood Leak (1250)

Patient Problems Confusion/ Disorientation (2553); Missed Dose (2561)

Event Date 04/23/2018

Event Type  malfunction  

Event Description

High pressure 3-way, luer-lock stopcock was placed on the patient's central line.The nurse had hooked up propofol through the stopcock (to keep ventilated patient sedated).The patient started to become agitated.Upon further investigation, the nurse found a puddle of propofol behind the patient.All the connections on the stopcock were tight but it was leaking.The stopcock was removed and there was no harm to the patient.

• Brand Name: HIGH PRESSURE 3-WAY, LUER-LOCK STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 7960040
• MDR Text Key: 123555928
• Report Number: 7960040
• Device Sequence Number: 1
• Product Code: FMG
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 42353-01
• Device Lot Number: 3620443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13870 DA