MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DUO-VENT CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8419

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Irritability (2421)

Event Date 02/01/2023

Event Type  Injury  

Event Description

It was reported that a patient was receiving an infusion of precedex at 11.22cc/hr.With a clearlink system solution set, indicated for treatment for alcohol withdrawal.According to the reporter, the patient "was very agitated, tangled up in the iv lines; trying to get out of bed".The iv tubing was found broken in three places and there was "a clean cut noticed on the tubing" and that the broken pieces "were farther towards the bottom of the tubing".The patient subsequently recovered from the agitation.No additional information is available.

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was received for evaluation.The returned sample has been primed with an unknown solution and one empty solution bag.Visual inspection with the naked eye revealed the tubing was cut into 3 sections.The male luer was not returned together with the unit.The reported condition was verified.The cause of the condition could not be determined; however, is likely due to a use error.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: e4, g2 and h10.The user facility submitted medwatch (b)(4) for this event.

• Brand Name: DUO-VENT CLEARLINK LUER ACTIVATED VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16473347
• MDR Text Key: 310585368
• Report Number: 1416980-2023-00792
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8419
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PRECEDEX; SPECTRUM PUMP
• Patient Outcome(s): Other