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

MAUDE Adverse Event Report: BAXTER ONE-LINK NEEDLE FREE IV CONNECTOR 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 ONE-LINK NEEDLE FREE IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemolysis (1886)
Event Date 09/05/2018
Event Type  malfunction  
Event Description
Labs drawn from clear pressure caps are hemolyzed. Staff reported increased incident of hemolyzed labs during use of one-link pressure caps.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameONE-LINK NEEDLE FREE IV CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER
25212 w. illinois route 120
round lake IL 60073
MDR Report Key7973676
MDR Text Key123985811
Report Number7973676
Device Sequence Number0
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2018
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/04/2018
Event Location No Information
Date Report to Manufacturer10/17/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-