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

Catalog Number 2R8538

Device Problems Disconnection (1171); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the luer of a clearlink system - non-dehp solution set was stripped off which allowed the equashield (non-baxter) to slip off.This was observed during checking.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction made to b5: it was reported that the luer of an unspecified quantity of clearlink system - non-dehp solution sets were stripped off which allowed the equashield (non-baxter) to slip off (previously submitted as one clearlink system - non-dehp solution set).H10: 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.

Manufacturer Narrative

Correction: this report is a duplicate of manufacturer report number 1416980-2023-01037.All information can be found under manufacturer report number 1416980-2023-01037.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK SYSTEM SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16513227
• MDR Text Key: 311058768
• Report Number: 1416980-2023-00942
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412676647
• UDI-Public: (01)00085412676647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 2R8538
• Device Lot Number: DR21J30031
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 04/05/2023; 04/26/2023
• Supplement Dates FDA Received: 04/12/2023; 05/23/2023
• Date Device Manufactured: 11/01/2021
• 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