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

Model Number	2C7461
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot #: the reported lot number is 00vl933109 which is not a valid baxter lot number.D4: unique identifier (udi) #: the lot number (10) and subsequent expiration date (17) are unknown; therefore, the udi number only will contain the device identifier (01).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the back flow valve of a clearlink system secondary medication set failed to work.The primary line was clamped; however, the secondary medication flowed into the primary bag of fluid during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H11: the device was not returned and the valid lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20176512
• Report Number: 1416980-2024-04863
• Device Sequence Number: 20923771
• Product Code: FPA
• UDI-Device Identifier: 00085412049069
• UDI-Public: (01)00085412049069
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: 2C7461
• Device Catalogue Number: 2C7461
• Device Lot Number: ASKU
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRIMARY BAG.
• Patient Sex: Unknown