MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7N8377
Medical Device Problem Codes	Crack (1135); Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Tachycardia (2095)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a one-link non-dehp y-type standard bore catheter extension set leaked.During an unspecified infusion, ¿the threading at the patient connection site¿ cracked, resulting in a loose connection of the tubing to the patient and therefore leaking medication.The solution was prescribed for sedation; consequently, the solution leak caused the patient to be under-sedated, resulting in tachycardia and hypertension until the leak was discovered.No further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information: h6 and h11.H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the photograph provided, the luer was observed to be broken.The reported condition was verified.However, due to the nature of the provided sample, no further testing could be performed.Therefore, the cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ONE-LINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21923489
• Report Number: 1416980-2025-02533
• Device Sequence Number: 21038148
• Product Code: FRN
• UDI-Device Identifier: 00085412091808
• UDI-Public: (01)00085412091808
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132734
• 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): 05/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7N8377
• Device Catalogue Number: 7N8377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 SOLUTION.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown