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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS HEALTHCARE MFG CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7220-24
Device Problem Separation Failure (2547)
Patient Problem Hyperglycemia (1905)
Event Date 06/07/2016
Event Type  Injury  
Manufacturer Narrative
Smiths medical has received the sample device. An investigation was performed and the device operated within specification.
 
Event Description
Patient reported that the cleo sets would not always release from the setter. This caused the patients' blood glucose increased to 500 mg/dl. No patient injury or intervention noted. Please reference mdr#s: 2183502-2016-01347, 2183502-2016-01348, 2183502-2016-01349 and 2183502-2016-01350 that are also associated with this complaint.
 
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Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana 55425
MX 55425
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana 55425
MX 55425
Manufacturer Contact
lisa perz
1265 grey fox rd
st. paul, MN 55112
7633833074
MDR Report Key5773070
MDR Text Key48887446
Report Number2183502-2016-01346
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
Report Date 06/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7220-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2016
Was Device Evaluated by Manufacturer? Yes
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: 07/06/2016 Patient Sequence Number: 1
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