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

Model Number	2C8857
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a vented paclitaxel set leaked keytruda from an unspecified location.This was observed under the mixing hood.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
B5: upon additional information, the leak occurred at the junction of tubing and drip chamber.H11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The set underwent priming, pressure, and clear passage underwater leak testing, and a leak was observed between the assembly of the tubing and the drip chamber.During dimensional inspection, the outer dimension of the tubing was not according to specification.A computed tomography (ct) scan analysis of the drip chamber confirmed that there was no interference between the components.The reported condition was verified.The cause of the condition was determined to be the lack of interference between the components, due to the tubing being out of specification.The lack of interaction could generate a leak channel between both components.The manufacturing site implemented quality controls to detect this defect in the future.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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19408758
• Report Number: 1416980-2024-02552
• Device Sequence Number: 8227333
• Product Code: FPA
• UDI-Device Identifier: 00085412046372
• UDI-Public: (01)00085412046372(10)R22I24154(17)270926
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160007
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 2C8857
• Device Catalogue Number: 2C8857
• Device Lot Number: R22I24154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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