• 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 Bent (1059)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
Four cleo® 90 infusion sets were returned for analysis in used conditions. Visual inspection revealed that the retractor was active and the base was missing. Relevant document were reviewed and deemed adequate. A review of manufacturing process was performed. Line clearance record, inserter assembly operation, training records, maintenance records of site threader were all reviewed; no discrepancies noted. Three samples from the production line was inspected and given the worse test cases. No detachment was detected. Based on the evidence no root cause was determined as the complaint was not confirmed.
 
Event Description
Information was received indicating that the catheter was bent to a smiths medical cleo® 90 infusion set. The patient reported a blood sugar higher than 340 requiring additional insulin to bring it to a therapeutic level. The patient recovered with no further adverse effects.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, 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.
a d no.4 parque industrial int
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, MN 55442
7633833310
MDR Report Key7067201
MDR Text Key195839074
Report Number3012307300-2017-02502
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/10/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/29/2017 Patient Sequence Number: 1
-
-