MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK SYSTEM T-CONNECTOR EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2N3328

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that four (4) interlink system non-dehp t-connector extension sets broke resulting in leak of intravenous (iv) solution; further described as ¿breaks off at the hub" that connects to the iv catheter "causing the iv to leak" (near to the t-connector and tubing junction).The leaks were discovered during unspecified process steps.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual devices were not available; however, a photograph of the sample was provided for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Due to the nature of the sample no further testing could be performed.The reported condition was not verified.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 SYSTEM T-CONNECTOR EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 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: 18185722
• MDR Text Key: 328707454
• Report Number: 1416980-2023-06089
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412004662
• UDI-Public: (01)00085412004662
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K921899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2N3328
• Device Lot Number: UR23F19017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED IV SOLUTION