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

Catalog Number 2N8378

Device Problem Disconnection (1171)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system non-dehp catheter extension set detached between the luer lock adapter and line.This issue was identified during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph using the naked eye which revealed that two piece luer lock assembly and the tubing was separated.The reported condition was verified.By the nature of the sample, no additional tests were performed.The cause of the condition could not be determined.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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12519507
• MDR Text Key: 272916783
• Report Number: 1416980-2021-05879
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048918
• UDI-Public: (01)00085412048918
• Combination Product (y/n): Y
• PMA/PMN Number: K112893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2N8378
• Device Lot Number: UR21D13067
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2021
• 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