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

Model Number	7N8378
Medical Device Problem Codes	Material Rupture (1546); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
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 the tubing of two (2) one-link standard bore catheter extension sets ruptured approximately an inch from the lock from flow issues.This was observed during a ct (computed tomography) pe (pulmonary embolism) study.The tubing was used with a ct, and there was no flow of fluid.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d4: expiration date (update the null value to n/a), h4, h6, h11.H11: the actual device was not available; a photo was provided for evaluation.However, the photo could not be opened to review the customer reported issue; therefore, a device analysis could not be completed.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: ONE-LINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; 600 mts oeste de entrada; las americas parque industrial; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21097676
• Report Number: 1416980-2024-07875
• Device Sequence Number: 8637206
• Product Code: FPA
• UDI-Device Identifier: 00085412091792
• UDI-Public: (01)00085412091792(10)R24G30192
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 7N8378
• Device Catalogue Number: 7N8378
• Device Lot Number: R24G30192
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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