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

Model Number	2N3328
Medical Device Problem Codes	Backflow (1064); Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4: weight - neonate patient of 1.3 kg.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was a crack near the distal end of an interlink non-dehp t-connector extension set which resulted in the patient¿s blood backing up into the line and leaking from the cracked distal end.During use of the interlink set, it was observed that blood backed up in the line, and when staff attempted to flush the set, a mixture of blood and saline was observed leaking from a crack near the distal end of the device.The crack was located on the distal end component/hard plastic where the flush connects.It was estimated that the neonate patient lost approximately 1¿2 ml of blood.The patient did receive a blood transfusion later that day; however, this was attributed to the patient¿s underlying condition and not necessarily related to the small volume of blood loss from the device issue, though it may have contributed marginally to timing.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d9, h3, and h6.H11 : the device was received for evaluation.Visual inspection revealed a crack at the microbore winged female luer lock adapter.A functional pressure test was conducted at 8 psi, during which continued bubbling was observed, indicating a leak.The reported condition was verified.Based on the evaluation, the condition is attributed to the manufacturing process.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: INTERLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd. 721, km. 0.3; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24503299
• Report Number: 1416980-2026-00831
• Device Sequence Number: 18670948
• Product Code: FPA
• UDI-Device Identifier: 00085412004662
• UDI-Public: (01)00085412004662(10)UR22C04178(17)320331
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K921899
• 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): 04/17/2026

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: 2N3328
• Device Catalogue Number: 2N3328
• Device Lot Number: UR22C04178
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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: SALINE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown