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

Model Number	B2163
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Per the report received, the patient was getting a blood transfusion through the iv tubing.About 50 minutes into the transfusion, the registered nurse (rn) noticed some blood splatter on the floor next to the isolette neonatal incubator.The rn then examined the set up of the transfusion, and noticed that there was a leak coming from the extension tubing, icu medical b2163.Rn then changed the tubing, and the new tubing was leaking in that same spot.She changed the tubing once more, and it was still leaking in that same area of the tubing.She then changed out the infusion pump and got different tubing to complete the transfusion.Health care providers do not have a lot of info, but the iv tubing that leaked is available if the manufacturer wants to examine them.

• 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: 14013650
• Report Number: 14013650
• Device Sequence Number: 5229958
• Product Code: FMG
• UDI-Device Identifier: 00887709003576
• UDI-Public: (01)00887709003576
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/28/2022
• Report Date (Section F): 03/28/2022

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: B2163
• Device Lot Number: 5441276
• 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: 04/05/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2022
• 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
• Patient Age: 30 DA
• Patient Sex: Male
• Patient Weight: 4 KG
• Patient Race: White
• Date Report Sent to FDA: 03/28/2022