MAUDE Adverse Event Report: BD SWITZERLAND SÀRL MAXPLUS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MP5301-C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The bd maxplus pressure rated extension set with clear needless adapter come apart from the iv catheter at the luer lock.

• Brand Name: MAXPLUS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD SWITZERLAND SÀRL; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 23050880
• Report Number: 23050880
• Device Sequence Number: 9769222
• Product Code: FPA
• UDI-Device Identifier: 10885403236600
• UDI-Public: (01)10885403236600
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 08/12/2025
• Report Date (Section F): 08/12/2025

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: MP5301-C
• Device Catalogue Number: MP5301-C
• 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: 09/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• 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: 08/12/2025