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

Catalog Number	2H7462
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during use of an unspecified quantity of clearlink system non-dehp secondary medication sets, there was difficulty to infuse the solution; the vents were opened to infuse the product.This was observed during use of the secondary sets with non-baxter primary sets; glass bottles and flexible containers were part of the set up.With the glass bottles, there was insufficient air ventilation.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and it was not possible to observe the reported condition through the picture.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: CLEARLINK/DUO-VENT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h11; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19568543
• Report Number: 1416980-2024-03031
• Device Sequence Number: 6948717
• Product Code: FPA
• UDI-Device Identifier: 00085412048543
• UDI-Public: (01)00085412048543(10)R24C04024(17)260305
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: Health Professional
• Device Expiration Date: 03/05/2026
• Device Catalogue Number: 2H7462
• Device Lot Number: R24C04024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALARIS PUMP; ALBUMIN; B BRAUN VENT SPIKE CONNECTOR; BD PRIMARY SET; UNSPECIFIED FLEXIBLE CONTAINERS
• Patient Sex: Unknown