MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; STOPCOCK, I.V. SET

Model Number	2C6204
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 large bore stopcocks did not create a continuous fluid path when connected with unspecified iv extension sets with needleless adapters.The issue was observed when trying to administer medication.When connected and opened, there was an inability to flush the stopcocks.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: d4: expiration date (update the null value to n/a), d9, h3, h4, h6 (update codes), h11.H11: one (1) actual device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure and clear passage under water testing were performed on the sample; flow was observed.The device was found to be within the product specifications.The reported condition was not verified.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: NA
• Common Device Name: STOPCOCK, I.V. SET
• 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: 24432372
• Report Number: 1416980-2026-00698
• Device Sequence Number: 10244256
• Product Code: FMG
• UDI-Device Identifier: 00085412001913
• UDI-Public: (01)00085412001913(10)DR25E02017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 2C6204
• Device Catalogue Number: 2C6204
• Device Lot Number: DR25E02017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED EXTENSION SETS W/ NEEDLELESS ADAPTERS; UNSPECIFIED MEDICATION
• Patient Sex: Unknown