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

Model Number	B1729
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Filter attachment to iv tubing occluded, fluid would not run during simponi aria infusion.Changed pumps, checked all ports and equipment.When required filter attachment was removed the occlusion was gone.Filter attachment was replaced and infusion was completed without further complication.Filter attachment part reference number b1729, lot 4799732, expiration 04/01/2025.

• 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: 10689709
• Report Number: 10689709
• Device Sequence Number: 17014909
• Product Code: FMG
• UDI-Device Identifier: 00887709073951
• UDI-Public: (01)00887709073951
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 10/05/2020
• Report Date (Section F): 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: B1729
• Device Catalogue Number: B1729
• Device Lot Number: 4799732
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 83
• Date Report Sent to FDA: 10/05/2020