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

Catalog Number 2R8538

Device Problems Disconnection (1171); Incomplete or Inadequate Connection (4037)

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

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

The user facility submitted medwatch mw5116176 for this event.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the luer lock of a clearlink system - non-dehp solution set was not screwing onto the non-baxter female closed system transfer device (cstd) adapter.The "tubing nut" would screw then fall off despite the luer lock threading being visible on both ends.This was identified during compounding.The issue resolved when the set was replaced.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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.

• 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: 16788859
• MDR Text Key: 313758987
• Report Number: 1416980-2023-01921
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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: DR21L15048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 05/26/2023
• 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
• Treatment: NA.