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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Bent (1059)
Patient Problem Hyperglycemia (1905)
Event Date 08/06/2017
Event Type  Injury  
Event Description
Information was received indicating that the adhesive to a smiths medical cleo® 90 infusion set stuck to the cap, causing the site to pull out of the applicator upon opening.It was attempted to put the site back into the applicator and try to use it.Blood sugar at time of incident was reported to be 420.The patient reported that the when reassembling into the applicator the cannula to bent upon insertion.The site was changed and a bolus of novolog insulin was given.No further adverse effects were reported.
 
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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.
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 Key7287631
MDR Text Key100643451
Report Number3012307300-2018-00332
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,distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 02/14/2018
Initial Date FDA Received02/21/2018
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
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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