MAUDE Adverse Event Report: BD SWITZERLAND SARL MAXGUARD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MXT1003
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Upon connecting the t-connector to iv catheter, it broke off upon twisting.T-connector was immediately disconnected from iv catheter, no harm to patient.Product bd maxguard pressure rated t-connector extension set (minibore).Lot #24079242.

• Brand Name: MAXGUARD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD SWITZERLAND SARL; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 21303776
• Report Number: 21303776
• Device Sequence Number: 8169591
• Product Code: FPA
• UDI-Device Identifier: 10885403237829
• UDI-Public: (01)10885403237829(10)24079242(17)290702
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2025
• Report Date (Section F): 01/29/2025

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
• Operator of Device: Health Professional
• Device Model Number: MXT1003
• Device Catalogue Number: MXT1003
• Device Lot Number: 24079242
• 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: 02/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2025
• 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: 01/29/2025