• 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 ASD, INC. JELCO CATHETER

  • 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 ASD, INC. JELCO CATHETER Back to Search Results
Catalog Number 8466
Device Problem Break (1069)
Patient Problem Phlebitis (2004)
Event Type  Injury  
Event Description
It was reported that the catheter caused mechanical phlebitis because the bezel cracked. Catheter is blunt, when administering the solution it opens up exposing the vein.
 
Manufacturer Narrative
The device was unable to be evaluated as it was not returned. If the device is received in the future an evaluation will be performed. The reported event was unable to be confirmed or replicated. A cause of the reported event could not be determined at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJELCO CATHETER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13862078
MDR Text Key287695303
Report Number3012307300-2022-05064
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8466
Device Lot Number3162119E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/22/2022
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

-
-