MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. INTERLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2N3328
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date/d10: concomitant product: this event occurred on an unspecified date in (b)(6) 2024.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that male portion of the luer lock adapter of two (2) interlink system non-dehp t-connector extension sets was damaged which prevented the connection to catheter hub.This was noticed while connecting during intravenous placement.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h4, and h6.H11: one actual device and one photographic sample were received for evaluation.The returned photograph was reviewed, and it was noted that the interlink t-conn, non-retractable male luer lock, with septum and the t-connector housing was damaged.A visual inspection of the actual sample was performed, and it was noted that the t-conn housing of the interlink t-conn, non-retractable male luer lock was observed damaged.The reported condition was verified.The cause of the reported condition was a manufacturing issue.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 INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19983796
• Report Number: 1416980-2024-04287
• Device Sequence Number: 11869912
• Product Code: FPA
• UDI-Device Identifier: 00085412004662
• UDI-Public: (01)00085412004662(10)UR24C27093
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 2N3328
• Device Catalogue Number: 2N3328
• Device Lot Number: UR24C27093
• 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: 07/19/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2024
• 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