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

Catalog Number	2N8374
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the luer lock (clearlink) of an unspecified quantity of clearlink system cath.Ext.Sets was hard to disconnect to attach a non-baxter blood collection set.This was observed during blood collection from patients.To resolve the event, the nurses would get a new extension set that could be disconnected to complete the blood collection procedure.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: two actual devices and photographs were received for evaluation.A visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional tests were performed which included check in-line luer connections, remove protector, open and close slide clamp and test the access to the luer activated valve; all had satisfactory results.Additionally, prime, purge air, pressure test, and clear passage tests were performed with no issues noted.Upon further examination, it was noted that the luer activated valve for the iv (intravenous) access and the microbore winged luer lock parts could not be disconnected by hand on both samples.The reported condition was verified.A visual inspection of a photograph revealed the clearlink was removed from the set to connect a non-baxter device as a blood collector.Therefore, the cause of the condition was determined to be a user related issue.The clearlink luer activated valve is an in-line injection site, which can be connected to standard male luer adapters (e.G., syringes or sets) for continuous or intermittent fluid administration or the withdrawal of fluids.The direction insert for the product does not indicate removal of the clearlink device from the set.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 LUER ACTIVATED VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18188193
• Report Number: 1416980-2023-06118
• Device Sequence Number: 7275519
• Product Code: FPA
• UDI-Device Identifier: 00085412048901
• UDI-Public: (01)00085412048901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2N8374
• Device Lot Number: UR23G18024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED BLOOD COLLECTION SET/VACUTAINER SLEEVE
• Patient Sex: Unknown