MAUDE Adverse Event Report: BD//BARD ACCESS SYSTEMS, INC. BD STATLOCK IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	00801741082047
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Bd statlock catheter stabilization device iv select - tubing burst open while being flushed.The defect occurred in the body of the tubing--not at any connection points.

• Brand Name: BD STATLOCK IV TUBING
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD//BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 24501010
• Report Number: MW5184635
• Device Sequence Number: 9870375
• Product Code: FPA
• UDI-Device Identifier: 00801741082047
• UDI-Public: (01)00801741082047(11)250807(17)280728
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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: 00801741082047
• Device Catalogue Number: IVO564
• Device Lot Number: JUKU1009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown