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

Catalog Number	2R8858
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a clearlink paclitaxel set leaked from the drip chamber.This was observed during patient infusion with a chemotherapy drug.The treatment was stopped to resolve the event.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter address: (b)(6).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.
Additional Manufacturer Narrative
H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK PACLITAXEL SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 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: 19234569
• Report Number: 1416980-2024-02057
• Device Sequence Number: 5855416
• Product Code: FPA
• UDI-Device Identifier: 00085412565774
• UDI-Public: (01)00085412565774
• 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): 06/12/2024

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: Other
• Device Expiration Date: 06/29/2024
• Device Catalogue Number: 2R8858
• Device Lot Number: R22F28093
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/12/2024
• Date Device Manufactured: 06/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CHEMOTHERAPY SOLUTION
• Patient Sex: Unknown