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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK NON-DEHP EXTENSION SET 0.2 MICRON DOWNSTREAM FILTER 16'', 5.1 ML; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER INTERNATIONAL INC. CLEARLINK NON-DEHP EXTENSION SET 0.2 MICRON DOWNSTREAM FILTER 16'', 5.1 ML; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2H8671
Device Problems Loose or Intermittent Connection (1371); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/15/2023
Event Type  malfunction  
Event Description
Clearlink non-dehp extension set 0.2 micron downstream filter lot # r22b28154.Threads on luer lock end defective.When attaching smart site to end (per protocol to use for chemotherapy infusion), smart site just "spins" continuously and does not tighten.The connection can then be disconnected very easily with a small amount of force.This is a risk for a chemo spill if tubing is pulled accidentally.Tested 2 other lot numbers which were found to be working properly.
 
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Brand Name
CLEARLINK NON-DEHP EXTENSION SET 0.2 MICRON DOWNSTREAM FILTER 16'', 5.1 ML
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
one baxter parkway
deerfield IL 60015
MDR Report Key16952058
MDR Text Key315455812
Report Number16952058
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/15/2023
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
Device Operator Health Professional
Device Model Number2H8671
Device Catalogue Number2H8671
Device Lot NumberR22B28154
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/15/2023
Event Location Hospital
Date Report to Manufacturer05/18/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/18/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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