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

Model Number MC330217

Device Problems Infusion or Flow Problem (2964); Priming Problem (4040)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2022

Event Type  malfunction  

Event Description

Clinical staff connected a new smoflipid to new icu medical small bore extension tubing set, but could not get the lipids to go through and prime the tubing.There were no kinks, it was unclamped.The healthcare provider detached, and reattached the syringe to ensure that the connection was correct and not askew.The healthcare provider was still unable to flush the lipids through the tubing.Healthcare provider saved the package and 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: 14631265
• MDR Text Key: 293536994
• Report Number: 14631265
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MC330217
• Device Catalogue Number: MC330217
• Device Lot Number: 5803837
• 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: 05/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1