MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2H7462
Medical Device Problem Codes	Disconnection (1171); 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 three (3) clearlink secondary medication sets disconnected from the iv (intravenous) bag which resulted in chemotherapy leakage.This occurred during set up prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction: this report is a duplicate of manufacturer report number 1416980-2024-06063.All information can be found under manufacturer report number 1416980-2024-06063.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK/DUO-VENT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; 600 mts oeste de entrada; las americas parque industrial; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20474291
• Report Number: 1416980-2024-05856
• Device Sequence Number: 20740445
• Product Code: FPA
• UDI-Device Identifier: 00085412048543
• UDI-Public: (01)00085412048543(10)R24D13048(17)260416
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K203609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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 Expiration Date: 04/16/2026
• Device Model Number: 2H7462
• Device Catalogue Number: 2H7462
• Device Lot Number: R24D13048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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