MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HIGH FLOW RATE EXTENSION SET, LUER LOCK ADAPTERS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2C9221
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of high flow rate extension sets were unable to be connected at the luer lock.This occurred prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction: d4.D4: expiration date: na.Additional information: h4, h6(update codes), h11.H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed on the sample, and all components were observed to be correctly positioned according to the specifications.However, the tip protector had a mark of damage that could not be identified.The reported condition could not be confirmed nor refuted.The cause of the issue could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HIGH FLOW RATE EXTENSION SET, LUER LOCK ADAPTERS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; parque industrial itabo; carretera sanchez km 18 1/2; haina 21426 ; DR 21426
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24769509
• Report Number: 1416980-2026-01174
• Device Sequence Number: 21401684
• Product Code: FPA
• UDI-Device Identifier: 00085412002996
• UDI-Public: (01)00085412002996(10)DR25J15031
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K811078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: Other
• Device Model Number: 2C9221
• Device Catalogue Number: 2C9221
• Device Lot Number: DR25J15031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown