Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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/CONTINU-FLO; 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/CONTINU-FLO; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2C8546
Device Problems Contamination (1120); Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/10/2023
Event Type  malfunction  
Event Description
Doctor opened up a new micro drip tubing to make an iv for the first pediatric patient.As she was assembling, she noticed a foreign body in the tubing, stuck and immobile on the inside of the tubing wall even when fluid was passed through the tubing.Additional tubing found with this abnormality in stock room.Manufacturer response for iv tubing, micro drop tubing (per site reporter) e-mail sent on [redacted date] with pictures and a request for the coordination of return for investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CLEARLINK/CONTINU-FLO
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
round lake IL 60073
MDR Report Key16852546
MDR Text Key314391528
Report Number16852546
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2C8546
Device Catalogue Number2C8546
Device Lot NumberR22J06062
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/25/2023
Event Location Hospital
Date Report to Manufacturer05/02/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-