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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL CLEO® 90 INFUSION SET SUBCUTANEOUS INFUSION SET

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SMITHS MEDICAL CLEO® 90 INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Catalog Number 21-7231-24
Device Problem Separation Failure (2547)
Patient Problem Hyperglycemia (1905)
Event Date 05/18/2016
Event Type  malfunction  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
Distributor reported on behalf of home-care patient that on the evening of (b)(6) 2016 the patient tried to insert 3 new infusion sites but all 3 of the sites stayed stuck to the inserter device instead of the patient's skin. A new site was tried and the adhesive stuck to her skin successfully. However, as a result, it took longer than expected to resume using the pump, and her blood glucose levels rose to the 180's. The patient required a bolus of insulin on the pump. No further health care was sought and no injury occurred. Related to mfr # 2183502-2016-01298, 2183502-2016-01294, 2183502-2016-01295, 2183502-2016-01296.
 
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Brand NameCLEO® 90 INFUSION SET
Type of DeviceSUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
SMITHS MEDICAL
1265 grey fox road
st. paul MN 55112
Manufacturer (Section G)
SMITHS MEDICAL
1265 grey fox rd.
st paul MN 55112
Manufacturer Contact
michele seliga
1265 grey fox road
st paul 55112
7633833052
MDR Report Key5763447
MDR Text Key48624586
Report Number2183502-2016-01297
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
Report Date 06/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2020
Device Catalogue Number21-7231-24
Device Lot Number75X167
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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