Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. CLEO® 90 INFUSION SET; 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
 

SMITHS MEDICAL, ASD, INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Occlusion Within Device (1423)
Patient Problem Hyperglycemia (1905)
Event Date 11/28/2017
Event Type  Injury  
Manufacturer Narrative
See the following: mfr 3012307300-2017-02584.Mfr 3012307300-2017-02585.Mfr 3012307300-2017-02586.Mfr 3012307300-2017-02587.Mfr 3012307300-2017-02588.
 
Event Description
It was reported that a patient experienced an occlusion while using a cleo® 90 infusion set during basal delivery.The patient's blood glucose level was 420 at the time of the event.The patient was instructed on how to test for an occlusion discovering the blockage was likely located at the site.No adverse health outcomes were reported from this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CLEO® 90 INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL, ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
avenida calidad no. 4
parque industrial internaciona
tijuana, baja california 22425
MX   22425
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7121039
MDR Text Key94962343
Report Number3012307300-2017-02583
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was the Report Sent to FDA? No
Date Manufacturer Received12/06/2017
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 Initial
Patient Sequence Number1
Treatment
NOVOLOG INSULIN
Patient Outcome(s) Required Intervention;
Patient Age31 YR
Patient Weight103
-
-