• 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 - TUNISIA I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR 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 - TUNISIA I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number EMC7109
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 01/10/2018
Event Type  malfunction  
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not returned; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported the sterile packaging of five (5) packages of female luer lock adapter with control-a-flo were damaged. The event occurred prior to use; therefore, there was no patient involvement. No additional information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameI.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - TUNISIA
tunis
Manufacturer (Section G)
BAXTER HEALTHCARE - TUNISIA
route de chebbaou
2021oued e
tunis
TS
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7233999
MDR Text Key104166838
Report Number1416980-2018-00486
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberEMC7109
Device Lot Number17D05T005
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 Received02/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-