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

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

  • 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
 

SMITHS MEDICAL INTERNATIONAL, LTD. JELCO IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L Back to Search Results
Catalog Number 4033-AI
Device Problem Fluid/Blood Leak (1250)
Patient Problem Burn(s) (1757)
Event Date 01/11/2022
Event Type  Injury  
Event Description
It was reported that children have extravasation injury's.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJELCO IV CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
1500 eureka park
ashford, kent TN25 4BF
UK TN25 4BF
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
1500 eureka park
ashford, kent TN25 4BF
UK TN25 4BF
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13550246
MDR Text Key285755745
Report Number3012307300-2022-03561
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
4033-AI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number4033-AI
Device Lot Number4205143
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

-
-