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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
Catalog Number 21-7220-24
Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Device Slipped (1584)
Patient Problem Hyperglycemia (1905)
Event Date 01/10/2015
Event Type  Injury  
Manufacturer Narrative
Involved lot numbers reported by customer: 76x072, 75x079, and 76x114. Possible expiration date: 04/28/2021, 04/28/2020, 07/28/2016. Possible device manufacturer's date: 05/05/2016, 04/20/2015, 07/20/2016. 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. Mfr# clarification: new registration number (b)(4) ((b)(4)) is now being used for mfr report number, replacing registration number (b)(4) ((b)(4)).
 
Event Description
It was reported that a cleo® 90 infusion set cannula fell off or failed to stick properly. It was noted that the infusion set fell off immediately or after an hour. The cannula may have slid over while the tape was in place. The patient's blood glucose was known to rise. The blood glucose was brought down by replacing the infusion set and administering a manual shot. No permanent injury was reported. See mfr: 3012307300-2016-00410, 3012307300-2016-00411, 3012307300-2016-00412, 3012307300-2016-00413, 3012307300-2016-00414, 3012307300-2016-00415, 3012307300-2016-00416, 3012307300-2016-00417, 3012307300-2016-00418, 3012307300-2016-00419, 3012307300-2016-00420, 3012307300-2016-00421, 3012307300-2016-00422, 3012307300-2016-00423, 3012307300-2016-00424, 3012307300-2016-00425, 3012307300-2016-00426, 3012307300-2016-00427, 3012307300-2016-00428, 3012307300-2016-00429, 3012307300-2016-00430, and 3012307300-2016-00431.
 
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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 Key6140776
MDR Text Key61308451
Report Number3012307300-2016-00409
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,other
Reporter Occupation Patient Family Member or Friend
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 Received12/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Catalogue Number21-7220-24
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 Received11/08/2016
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 Initial

Patient Treatment Data
Date Received: 12/02/2016 Patient Sequence Number: 1
Treatment
T-SLIM PUMP
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