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

Catalog Number 2N8399

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported an unspecified quantity of clearlink luer activated valves leaked.It was further reported during ct/mri the ivs are having "blow outs".The events occurred during "high pressure contrast studies".It was further reported the clearlink luer activated valves are not recommended with high contrast injections.There was no report of patient injury or medical intervention associated with this event.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 devices were 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 LUER ACTIVATED VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12548478
• MDR Text Key: 273836361
• Report Number: 1416980-2021-05998
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048895
• UDI-Public: (01)00085412048895
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2N8399
• Device Lot Number: SR21C15119
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• 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
• Treatment: CONTRAST; CONTRAST