• 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, IV

  • 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, IV Back to Search Results
Lot Number 3491237
Device Problem Obstruction of Flow (2423)
Patient Problem No Code Available (3191)
Event Date 06/20/2018
Event Type  malfunction  
Event Description
The nicu staff is reporting multiple problems with the smiths medical jelco 24g 5/8" protect iv catheter. Over the last several months the staff reports that among a healthcare team that performs peripheral vascular access on neonatal patients the staff has had repeated problems with the catheter not exhibiting a flash back of blood, including those that are performed with the assistance of a venous illuminator, where venous access can be validated. The problem has created multiple iv access attempts on a very vulnerable patient population and even those infants that are full term with easily accessible access. The educational staff worked with the staff to assist with any technique issues but the problem has been reoccurring. The department is now trialing a catheter from a different manufacturer. Nicu and materials management contacted smiths medical and the product surveillance department. The surveillance team asked for additional information in order to further investigate by members of their quality team.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJELCO
Type of DeviceCATHETER, IV
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7673257
MDR Text Key113528297
Report Number7673257
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2018
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number3491237
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/26/2018
Event Location Hospital
Date Report to Manufacturer07/10/2018
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

-
-