MAUDE Adverse Event Report: ICU MEDICAL, INC. SECONDARY IV TUBING 37" 15 DROP SECONDARY ADMIN SET WITH BAG HANGER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	SF3258-15H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Ivig secondary tubing leaking out vent.

• Brand Name: SECONDARY IV TUBING 37" 15 DROP SECONDARY ADMIN SET WITH BAG HANGER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC. ; san clemente CA 92673
• MDR Report Key: 7478897
• Report Number: MW5076950
• Device Sequence Number: 1543258
• Product Code: FPA
• UDI-Device Identifier: 00840619046200
• UDI-Public: 00840619046200
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: SF3258-15H
• Device Lot Number: 3622590
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR