• 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 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 SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Fluid Leak (1250); Failure to Disconnect (2541)
Patient Problem Eye Injury (1845)
Event Date 05/18/2016
Event Type  Injury  
Manufacturer Narrative
Complaint no: (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A nurse experienced a connection issue which resulted in the splashing of an unknown intravenous (iv) medication solution into their left eye. The connection issue was further described as the baxter secondary iv infusion access was stuck on the port of unknown primary iv infusion set and while trying to remove the secondary line the nurse was splashed in the eyes with the unknown secondary medication solution. It was unknown what solutions were in the primary or secondary sets. The nurse was offered as a precaution, unspecified prophylactic medications; however, the nurse declined the treatment. Outcome of the event was not reported. No additional information is available.
 
Manufacturer Narrative
(b)(4). The sample was not returned for evaluation and the lot number is unknown, therefore a device analysis could not be performed. Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5723920
MDR Text Key47361071
Report Number1416980-2016-10700
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
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 06/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received06/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/14/2016 Patient Sequence Number: 1
-
-