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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SECONDARY MEDICATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION CLEARLINK SECONDARY MEDICATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number JC7453
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that two (2) clearlink system secondary medication sets came apart where the tubing enters the luer lock.This occurred during preparation.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
: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.
 
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Brand Name
CLEARLINK SECONDARY MEDICATION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key9532534
MDR Text Key173197283
Report Number1416980-2019-07257
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/27/2020
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 Other
Device Catalogue NumberJC7453
Device Lot NumberSR19G26081
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received01/02/2020
Supplement Dates FDA Received01/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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