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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 2C7461
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2022
Event Type  malfunction  
Event Description
It was reported that a clearlink system secondary medication set leaked at the distal end. The 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
Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameCLEARLINK SECONDARY MEDICATION SET
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 Key15250371
MDR Text Key302281708
Report Number1416980-2022-04326
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203609
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2C7461
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/18/2022
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

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