MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; I.V. START KIT

Model Number	DYNDV2338A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Open piv [peripheral intravenous line] start kit to prime the tubing extension set that was included.No male leur end of tubing was missing.Tubing was open ended.

• Brand Name: MEDLINE
• Common Device Name: I.V. START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1160 s. northpoint blvd.; waukegan IL 60085
• MDR Report Key: 24267827
• Report Number: 24267827
• Device Sequence Number: 10722931
• Product Code: LRS
• UDI-Device Identifier: 10193489197150
• UDI-Public: (01)10193489197150
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/23/2026
• Report Date (Section F): 01/23/2026

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
• Device Model Number: DYNDV2338A
• Device Catalogue Number: DYNDV2338A
• Device Lot Number: (10)25KBT130
• 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: 02/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• 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: 01/23/2026