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U.S. Department of Health and Human Services

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

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SMITHS HEALTHCARE MFG CLEO® 90 INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Catalog Number 21-7231-24
Device Problems Sticking (1597); Component Missing (2306); Packaging Problem (3007)
Patient Problem Hyperglycemia (1905)
Event Date 06/09/2016
Event Type  Injury  
Manufacturer Narrative
Additional 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. Lot number 75x178 also provided, but no specifics were included as to what device issue applied to which lot.
 
Event Description
Device distributor reported on behalf of the home care user that the patient had several defective cleo's. When the package was open, it was stated that "most" of them had the adhesive patch stuck on the lid and "some" of them had the adhesive patch completely missing. (specifics on which/how many per lot was not provided). The patient's blood glucose rose to 300 mg/dl and he required multiple daily injections. Trace ketones were noted. No injury was reported. Refer to mfr # 2183502-2016-01432, 2183502-2016-01433, 2183502-2016-01434, 2183502-2016-01435, 2183502-2016-01436, 2183502-2016-01438, 2183502-2016-01439, 2183502-2016-01440, 2183502-2016-01441, 2183502-2016-01442, 2183502-2016-01443, 2183502-2016-01444, 2183502-2016-01445, 2183502-2016-01446, 2183502-2016-01447, 2183502-2016-01448, 2183502-2016-01449, 2183502-2016-01450, 2183502-2016-01451, 2183502-2016-01452, 2183502-2016-01453, 2183502-2016-01454, 2183502-2016-01455, 2183502-2016-01456, 2183502-2016-01457, 2183502-2016-01458, 2183502-2016-01459, 2183502-2016-01460, 2183502-2016-01461.
 
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Brand NameCLEO® 90 INFUSION SET
Type of DeviceSUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
SMITHS HEALTHCARE MFG
s.a.dec.v. ave, calidad no. 4
parque industrial internaciona
tijuana, bc 22425
MX 22425
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a.dec.v. ave, calidad no. 4
parque industrial internaciona
tijuana, bc 22425
MX 22425
Manufacturer Contact
lisa perz
1265 grey fox road
st paul 55112
7633833074
MDR Report Key5790639
MDR Text Key49425867
Report Number2183502-2016-01437
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 06/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2020
Device Catalogue Number21-7231-24
Device Lot Number75X172
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 Received06/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2015
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: 07/13/2016 Patient Sequence Number: 1
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