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

Model Number	2R8401
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the lot number (10) is unknown; therefore, the udi number only will contain the device identifier (01).G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of an unspecified quantity of interlink system non-dehp i.V.Catheter extension sets leaked an unspecified chemotherapy solution.The leak was observed at the junction between the drip chamber and tubing.The event occurred during an unknown process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H4: the device was manufactured between 09/04/2023 - 09/05/2023.H11: the actual device was not available; however, four (4) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The sets underwent pressure and clear passage under water testing and the devices all performed according to product specifications.The sets also were primed, and no leaks or issues were noted.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.
Additional Manufacturer Narrative
Corrected information: d1: brand name, d4: model#, d4: catalogue#, d4: lot#, d4: lot#, d4: expiration date, d4: unique identifier (udi)#, g1: device manufacturer name, g1: device manufacturer address 1, g1: device manufacturer city, g1: device manufacturer state, g1: device manufacturer country, g1: device manufacturer postal code, and g4: pma/510k # or bla #.H11: upon further follow up, the device 2n3374 does not have a drip chamber and the customer corrected the device product code to be 2r8401 with lot number: r23i02130.The evaluation of the 4 companion samples are of the product code: 2r8401 with lot number: r23i02130.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 h11; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20033063
• Report Number: 1416980-2024-04423
• Device Sequence Number: 15058781
• Product Code: FPA
• UDI-Device Identifier: 00085412565767
• UDI-Public: (01)00085412565767(10)R23I02130(17)250901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180739
• 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,Followup
• Report Date (Section B): 09/27/2024

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: 09/01/2025
• Device Model Number: 2R8401
• Device Catalogue Number: 2R8401
• Device Lot Number: R23I02130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 09/27/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/27/2024; 09/27/2024
• 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: UNSPECIFIED CHEMOTHERAPY SOLUTION.
• Patient Sex: Unknown