MAUDE Adverse Event Report: FRESENIUS KABI AG FENWAL BLOOD COMP. RECIPIENT SET WITH STD. BLOOD FILTER WITH LUER ADAPTER; SET, BLOOD TRANSFUSION

Model Number	4C2160
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Registered nurse (rn) was preparing to give a blood transfusion to a neonate patient.She began by priming the tubing, but as she did, the tubing immediately began to leak.It was leaking at the filter.The patient was never hooked up to the tubing, thus i did not include patient information in this report.The rn got new tubing, completed priming, and then the patient got the transfusion.

• Brand Name: FENWAL BLOOD COMP. RECIPIENT SET WITH STD. BLOOD FILTER WITH LUER ADAPTER
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): FRESENIUS KABI AG; three corporate drive; 2nd floor; lake zurich IL 60047
• MDR Report Key: 20332594
• Report Number: 20332594
• Device Sequence Number: 18166918
• Product Code: BRZ
• UDI-Device Identifier: 04052682004148
• UDI-Public: (01)04052682004148
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/26/2024
• Report Date (Section F): 06/26/2024

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 Model Number: 4C2160
• Device Catalogue Number: 4C2160
• Device Lot Number: FA24C18099
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2024
• 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 Sex: Unknown
• Date Report Sent to FDA: 06/26/2024