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

Model Number	B2128
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This rn and sedation doctor noticed air pockets throughout three connected mri tubing, while sedating a patient in mri.No large air pockets were present when propofol was initially primed.This rn reprimed the tubing multiple times and air bubbles were observed after each priming.Once this rn observed all air bubbles gone in tubing.Tubing was attached to patient and propofol drip was started.After starting propofol, this rn and dr.[redacted] observed large air pockets forming at one of the connection sites between mri tubing.Drip was stopped before air got to the patient and faulty tubing was removed before restarting propofol drip.

• Brand Name: ICU MEDICAL
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 24578943
• Report Number: 24578943
• Device Sequence Number: 21451298
• Product Code: FMG
• UDI-Device Identifier: 00887709003309
• UDI-Public: (01)00887709003309
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2026
• Report Date (Section F): 01/21/2026

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 Model Number: B2128
• Device Catalogue Number: B2128
• Device Lot Number: 14143720
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/21/2026