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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CONTINU-FLO INTERLINK SYSTEM SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CONTINU-FLO INTERLINK SYSTEM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H6519
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Patient Involvement (2645)
Event Date 08/18/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported two (2) non-dehp continu-flo solution sets were unable to connect to an interlink system non-dehp y-type catheter extension set. It was further reported, when the distal end of the continu-flo solution set is connected to the interlink extension set¿s and the ¿luer is advanced, the luer does not feel secure and can spin back¿. There was no patient involvement. No additional information is available.
 
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Brand NameCONTINU-FLO INTERLINK SYSTEM
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10532584
MDR Text Key206929578
Report Number1416980-2020-05689
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K123868
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2H6519
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2020
Was Device Evaluated by Manufacturer? Yes
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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