MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2C7461
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified access set had leakage at the connection point.This occurred during patient infusion with azithromycin (abx) prior to "cs" (cesarean section).The issue was further described as, an adapter was used to connect the abx to an unspecified 250 ml bag and applied piggyback tubing to connect to the primary tubing.However, a leak was observed at the connection point, resulting in leakage from all around the area.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the product code (01) and lot number (10) are unknown; therefore, the udi is not available.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: b5, d1, d4, d9, d10: concomitant product (update "piggy back tubing"), e1, g1, g4: pma/510k #, h3, h6 (update codes), h11.B5: update "unspecified access set" to "secondary medication set".H11: the device was received for evaluation spiked to a non-baxter adapter and vial.A visual inspection was performed using the unaided eye and all baxter-controlled components were observed to be correctly assembled and within specification; no visible defects, damage, or abnormalities were noted.Pressure and clear passage testing was performed and no leaks, air bubbles, or material defects were observed on the baxter secondary set or baxter-controlled components.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; parque industrial de cartago; apartado no. 1-7052; cartago ; CS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22569873
• Report Number: 1416980-2025-03857
• Device Sequence Number: 9237548
• Product Code: FPA
• UDI-Device Identifier: 00085412049069
• UDI-Public: (01)00085412049069
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K203609
• 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): 04/21/2026

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: Health Professional
• Device Model Number: 2C7461
• Device Catalogue Number: 2C7461
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ABX.; ADAPTER.; PIGGY BACK TUBING.; UNSPECIFIED BAG.; UNSPECIFIED PRIMARY TUBING.
• Patient Sex: Unknown