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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8671
Device Problems Fitting Problem (2183); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2021
Event Type  malfunction  
Manufacturer Narrative
The user facility submitted medwatch (b)(4) for this event. (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a clearlink system non-dehp extension set would not connect. It was further reported that the part labeled with 1 (female adapter) was misshaped. This was observed when trying to attached the filter to the patient. 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 SOLUTION ADMINISTRATION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
see h10
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12367904
MDR Text Key268151011
Report Number1416980-2021-05235
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K153158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2H8671
Device Lot NumberASKU
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 Received09/22/2021
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

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