• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number UC8519
Device Problems Disconnection (1171); Incomplete or Inadequate Connection (4037)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2021
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 continu-flo solution sets had connection issues. When attempting to connect the tubing prior to spiking, the device would ¿continue to rotate around and not provide a tight fit¿. Then during prime, the line would ¿easily come apart¿. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
carretera sanchez km 18.5
parque industrial itabo, piisa
haina san cristobal
DR
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key11581479
MDR Text Key245939007
Report Number1416980-2021-01656
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K961225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUC8519
Device Lot NumberDR20I26044
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-