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

Catalog Number 2R8858

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

It was reported that a clearlink, paclitaxel set leaked somewhere between the pump segment and filter.The issue was identified during an unspecified process step, before leaving the intravenous (iv) room.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.The reported condition is not clearly observed via the provided photograph and due to the nature of the returned sample no additional testing could be performed.Therefore, the reported event could not be objectively 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 PACLITAXEL 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 ; 2242702068
• MDR Report Key: 15251342
• MDR Text Key: 302407796
• Report Number: 1416980-2022-04328
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412565774
• UDI-Public: (01)00085412565774
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: 2R8858
• Device Lot Number: R22C26116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2022
• 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