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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 Bent (1059); Kinked (1339)
Patient Problem Hyperglycemia (1905)
Event Date 11/28/2016
Event Type  Injury  
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
It was reported that the cleo® 90 infusion sets were bent and kinked. The patient stated that his blood glucose rose to over the 500'smg/dl due to him running out of supplies. Thus; he switched to manual daily injections to manage his blood glucose levels. He also contacted his distributor regarding the infusion set issue. The distributor put in a new order for more supplies to be delivered to him. No permanent adverse effects to patient reported. See mfr # 3012307300-2017-00047, 3012307300-2017-00048, 3012307300-2017-00050, 3012307300-2017-00051, 3012307300-2017-00052.
 
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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
internacional, tijuana,, B.C. 2242
MX B.C. 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6238317
MDR Text Key64422570
Report Number3012307300-2017-00049
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 12/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2021
Device Catalogue Number21-7220-24
Device Lot Number76X121
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 Received12/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2016
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: 01/10/2017 Patient Sequence Number: 1
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