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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 Problems Bent (1059); Product Quality Problem (1506); Device Dislodged or Dislocated (2923)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation. (b)(4).
 
Event Description
It was reported that a cleo 90 infusion set adhesive had issues and caused the cannula to become dislodged and bent. The patient's blood glucose levels were adversely affected and reported at greater than 399mg/dl. The patient changed the site and delivered correction bolus or administered an injection to address the high blood glucose. No permanent injury was reported. See mfr: 3012307300-2016-00016, 3012307300-2016-00017, 3012307300-2016-00028, 3012307300-2016-00029, 3012307300-2016-00030, 3012307300-2016-00031, 3012307300-2016-00032, 3012307300-2016-00033, 3012307300-2016-00034, 3012307300-2016-00035, 3012307300-2016-00036, 3012307300-2016-00037, 3012307300-2016-00038, 3012307300-2016-00039, 3012307300-2016-00040, 3012307300-2016-00041, 3012307300-2016-00043, 3012307300-2016-00044, and 3012307300-2016-00045.
 
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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 MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6017159
MDR Text Key57053135
Report Number3012307300-2016-00042
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
Type of Report Initial,Followup
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2016
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 Unkown

Patient Treatment Data
Date Received: 10/11/2016 Patient Sequence Number: 1
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