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

Model Number	2R8480
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G1: device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of clearlink, non-dehp solution sets had particulate matter (pm) in the tubing right above the filter.The pm was described as ¿white discolored section in the tubing right about the filter¿ and ¿white substance can be scraped off the tubing¿.The pm was identified prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
B5: upon additional information, 'the majority of 4 units were affected.' h11: two (2) actual devices were received for evaluation.Visual inspection was performed which noted a solvent residue mark at the filter.The solvent application and the interaction between the filter and the solvent creates a physical reaction that produced the white marks.Further analysis via fourier transform infrared spectroscopy (ftir) test identified the mark as intrinsic material with the same composition of the tubing.No embedded particle in the samples.The marks were identified as intrinsic material with the same composition of the tubing, confirming no presence of particulate in the tubing.The failure mode was replicated using an unused filter, tubing and solvent 70/30 cyclohex/mek, the reported condition is considered an expected product characteristic due the interaction with the solvent 70/30 cyclohex/mek.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: 19807354
• Report Number: 1416980-2024-03786
• Device Sequence Number: 7524890
• Product Code: FPA
• UDI-Device Identifier: 00085412565750
• UDI-Public: (01)00085412565750(10)R24C25024(17)260326
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2024

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: 03/26/2026
• Device Model Number: 2R8480
• Device Catalogue Number: 2R8480
• Device Lot Number: R24C25024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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
• Patient Sex: Unknown