MAUDE Adverse Event Report: ICU MEDICAL INC. SECONDARY IVIG TUBING 37

Catalog Number	SF3258-15H
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Secondary tubing leaking out vent with ivig when changing bottles.

• Brand Name: SECONDARY IVIG TUBING 37
• Common Device Name: SECONDARY IVIG TUBING 37
• Manufacturer (Section D): ICU MEDICAL INC. ; san clemente CA 92673
• MDR Report Key: 7482465
• Report Number: MW5076998
• Device Sequence Number: 13895376
• 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): 05/01/2018

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: No Information
• Device Expiration Date: 02/01/2023
• Device Catalogue 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: 05/02/2018
• 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: 54 YR