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

Catalog Number 2C8858

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that a clearlink paclitaxel set leaked due to a separation of bonded components.The leak occurred on the pump segment of the tubing.This occurred during compounding prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

G1: device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed, and it was noted that there was a leak due to a hole in the tubing.Functional testing included pressure testing and clear passage under water testing, and it was noted that there was a leak from a hole in the tubing.The reported condition was verified.The cause of the reported condition was a manufacturing issue.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 SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18606773
• MDR Text Key: 334186104
• Report Number: 1416980-2024-00233
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412071688
• UDI-Public: (01)00085412071688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8858
• Device Lot Number: R23H18079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1