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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 Sticking (1597); Component Missing (2306); Separation Failure (2547)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
Smiths medical received three cleo® 90 infusion set without original packaging for analysis (one was received in used condition, one in unused condition, one white cap with adhesive stuck in the top). Upon visual examination two samples with the adhesive stuck in the white cap and one did not have the adhesive noted. Relevant documents and operations were reviewed and deemed adequate. Production floor inventory review was conducted on 32 units in order to inspect the skin adhesive with no discrepancies were detected. Based on the evidence the complaint was confirmed. However, the root cause is unknown. Smiths medical received three cleo® 90 infusion set for analysis. However, it is not known as to which set is related to which report. Two reportable complaints (3012307300-2012-01039-240991, 3012307300-2012-01040-240992) and one non-reportable ((b)(4)).
 
Manufacturer Narrative
It was reported on (b)(6) 2017 that the event happened "within the last 10-15 days". The exact date is unknown. 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 adhesive of a cleo® 90 infusion set was stuck to the cap. The patient's blood glucose levels were over 300 mg/dl at the time of the event. Patient administered an insulin injection in order to address the high blood glucose levels. No permanent injury was reported. See mfr: 3012307300-2017-01035, 3012307300-2017-01037, 3012307300-2017-01038, and 3012307300-2017-01040.
 
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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
jennifer meng
6000 nathan lane north
minneapolis, MN 55442
7633833078
MDR Report Key6570502
MDR Text Key117876944
Report Number3012307300-2012-01039
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
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 01/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/18/2021
Device Catalogue Number21-7220-24
Device Lot Number76X168
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Yes
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: 05/16/2017 Patient Sequence Number: 1
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