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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 2H8401
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(6). (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the male luer lock of a clearlink system non-dehp solution set had a connection issue to the cap of the patient¿s catheter iv. This issue was further described as, ¿the end of the connector keeps turning without securing the connection to the cap of the catheter iv. ¿ this issue was observed at the time of patient connection after priming was completed. There was no 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 - CARTAGO
see h10
see h10
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10734819
MDR Text Key213052002
Report Number1416980-2020-06644
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K112893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2H8401
Device Lot NumberR20E08057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2020
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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