MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; STOPCOCK, I.V. SET

Model Number A1141

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 08/07/2021

Event Type  malfunction  

Event Description

Lipids noted to be leaking from icu medical 9.5" smallbore trifuse ext set, but not at the tubing connection.The leaking was below where the max cap is attached to the tubing.

• Brand Name: ICU MEDICAL
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 12364727
• MDR Text Key: 268055381
• Report Number: 12364727
• 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: 08/18/2021

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: No Information
• Device Model Number: A1141
• Device Catalogue Number: A1141
• Device Lot Number: 5018845
• 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: 08/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 DA