MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK; SET, BLOOD TRANSFUSION

Model Number	2C8750
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a y-type blood/solution set had holes in the tubing, resulting in leakage of normal saline.The event occurred while the user was preparing to administer a unit of blood.The user spiked the normal saline bag and then, the blood unit.During priming with normal saline, fluid rapidly leaked from the tubing onto the floor.Upon inspection, holes were identified in the tubing at the clamp section on both the normal saline and blood lines.The user attempted to switch the unit of blood to a new tubing; however, was unable to remove the tubing.During further inspection, the tubing looked ¿perforated¿ and after manipulation, the tubing ripped larger with a whole chunk of the tubing coming off.A new blood unit and tubing would be used to continue the preparation.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d4: expiration date (update the null value to n/a), h4, h6(update codes), h11.H11: the actual device was not available; however, three (03) photographs of the sample were provided for evaluation.Visual inspection of the photographs showed a cut in the tubing.The reported condition was verified.The cause of the condition 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: CLEARLINK
• Common Device Name: SET, BLOOD TRANSFUSION
• 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: 25209694
• Report Number: 1416980-2026-01683
• Device Sequence Number: 13380311
• Product Code: BRZ
• UDI-Device Identifier: 00085412046341
• UDI-Public: (01)00085412046341(10)DR25I15062
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: 2C8750
• Device Catalogue Number: 2C8750
• Device Lot Number: DR25I15062
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NORMAL SALINE BAG; UNIT OF BLOOD
• Patient Sex: Unknown