MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2H7462
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a 'space' was formed between the spike of an unspecified quantity of clearlink system non-dehp secondary medication sets and non-baxter solution bag ports; there was no solution spillage.This was observed during use of the sets.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The actual devices were not available; however, two (02) photographs of sample(s) were provided for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition; however, a gap was identified between the spike and bag in a photo.The reported condition was verified.The cause of gap could not be determined.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: CLEARLINK/DUO-VENT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 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: 20614096
• Report Number: 1416980-2024-06327
• Device Sequence Number: 7453490
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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 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: 10/09/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 500ML ICU MEDICAL BAGS
• Patient Sex: Unknown