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

Device Problems Failure To Adhere Or Bond (1031); Kinked (1339); Device Dislodged or Dislocated (2923)

Patient Problem Hyperglycemia (1905)

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

The customer reported on behalf of the patient that over the previous year she experienced issues with her infusion sets ranging from adhesion issues, detaching during use and kink.The patient estimates approximately 15 were effected all together.The occurrence dates of these sets are unknown.The patient's blood glucose was affected where the highest was over 300 mg/dl, so the patient changed out supplies and performed boluses to decrease blood glucose.Please reference mdrs: 2183502-2016-01600, 2183502-2016-01601, 2183502-2016-01602, 2183502-2016-01603, 2183502-2016-01604, 2183502-2016-01606, 2183502-2016-01607, 2183502-2016-01608, 2183502-2016-01609, 2183502-2016-01610, 2183502-2016-01611, 2183502-2016-01612, 2183502-2016-01613, 2183502-2016-01614.That are also associated with this complaint.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, 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 Key: 5825591
• MDR Text Key: 50529623
• Report Number: 2183502-2016-01605
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• 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 Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR