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

Model Number MC33892

Device Problems Infusion or Flow Problem (2964); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2021

Event Type  malfunction  

Event Description

Closed medication administration infusion set being utilized on unit for medication administration with flush to follow for infusion via central lines.Unit has experienced three events in last month where normal saline bag attached to set, intended to allow for flush fluid to be pulled into syringe via one way valve has inadvertently infused into the patient.Volume of 90-180ml additional administered over several hours that was not intended.First event, device lot # not provided.Two events, same lot #.

Event Description

Closed medication administration infusion set being utilized on unit for medication administration with flush to follow for infusion via central lines.Unit has experienced three events in last month where normal saline bag attached to set, intended to allow for flush fluid to be pulled into syringe via one way valve has inadvertently infused into the patient.Volume of 90-180ml additional administered over several hours that was not intended.First event, device lot # not provided.Two events, same lot #.

• 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: 13598803
• MDR Text Key: 286131715
• Report Number: 13598803
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/11/2022,02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MC33892
• Device Catalogue Number: MC33892
• Device Lot Number: 5711361
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2022
• Date Report to Manufacturer: 02/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 510 DA
• Patient Sex: Male
• Patient Weight: 10 KG
• Patient Race: White