MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2R8858
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a clearlink, paclitaxel set leaked right under the drip chamber, "where the line connects".This occurred while priming the tubing with saline.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
D4: lot #: the suspect lot # was either r23d27055 or r24b17062.D4: expiration date: suspect lot r23d27055 has an expiration date of 04/27/2025 and suspect lot r24b17062 has an expiration date of 02/19/2026.D4 udi # (additional): suspect lot r23d27055 has an udi # (b)(4) and suspect lot r24b17062 has an udi # (b)(4).E1: initial reporter address: (b)(6); e1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
D4: there are two more suspected lot numbers r24a17093 and r24b19024 including r23d27055 and r24b17062.D4: expiration date: suspected lot r24a17093 has an expiration date of 01/18/2026.And suspected lot r24b19024 has an expiration date of 02/20/2026.D4 udi # (additional): suspect lot r24a17093 has an udi # (b)(4) and suspect lot r24b19024 has an udi # (b)(4).H4: device manufacture date: the lot r23d27055 was manufactured on 04/27/2023.The lot r24b17062 was manufactured on 02/19/2024.The lot r24a17093 was manufactured on 01/19/2024.The lot r24b19024 was manufactured on 02/20/2024.H11: the actual device was received for evaluation.A visual inspection was performed, and it was noted that the assembly of the tubing and drip chamber was not according to specification.The assembly was slightly below the first reference line for the drip chamber.Pressure test and clear passage under water were performed, and it was noted that there was a leak between the assembly of the tubing into the drip chamber.Priming was also performed, and it was noted that there was a leak between the assembly of the tubing and the drip chamber.The reported condition was verified.The cause of the reported condition was improper assembly method; a low insertion could generate a lack of interference in some areas of the joint of the tubing and the drip chamber.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 HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; 600 mts oeste de entrada; las americas parque industrial; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20667291
• Report Number: 1416980-2024-06492
• Device Sequence Number: 12588987
• Product Code: FPA
• UDI-Device Identifier: 00085412565774
• UDI-Public: (01)00085412565774
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160007
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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 Model Number: 2R8858
• Device Catalogue Number: 2R8858
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/12/2024
• 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
• Patient Sex: Unknown