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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2N8399
Device Problem Fluid 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.
 
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Brand NameCLEARLINK LUER ACTIVATED VALVE
Type of DeviceSET, 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 
2242702068
MDR Report Key12548478
MDR Text Key273836361
Report Number1416980-2021-05998
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K112893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2N8399
Device Lot NumberSR21C15119
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/29/2021 Patient Sequence Number: 1
Treatment
CONTRAST
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