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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 Problem Kinked (1339)
Patient Problem Hyperglycemia (1905)
Event Date 04/02/2017
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.
 
Event Description
It was reported that the cannula of a cleo® 90 infusion set was kinked. The patient's blood glucose levels were 350 mg/dl at the time of the event. Patient did not have ketones. To address the high blood glucose levels, the patient administered manual injections. Patient also changed her infusion site. No permanent injury was reported. See mfr: 3012307300-2017-00974, 3012307300-2017-00976, and 3012307300-2017-00977.
 
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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, 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key6541784
MDR Text Key74333876
Report Number3012307300-2017-00975
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 05/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/17/2021
Device Catalogue Number21-7220-24
Device Lot Number76X167
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 Received04/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2016
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: 05/03/2017 Patient Sequence Number: 1
Treatment
HUMALOG INSULIN
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