MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7230

Device Problem Device Operational Issue (2914)

Patient Problem Hyperglycemia (1905)

Event Date 01/28/2016

Event Type  malfunction  

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 during application of the listed device it would not stick.User's blood glucose level increased to 290 mg/dl as a result of this event.No adverse health outcome reported.

Manufacturer Narrative

The reported cleo set, insulin, 9mm inserter/ retractor, 24" buckle was returned for investigation.The returned device was received inside a plastic bag without its original packaging.Visual inspection was at a distance of 12" to 24" and normal conditions of illumination and detected the adhesive was stuck to the white cap.The complaint was confirmed.

• Brand Name: CLEO INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5439771
• MDR Text Key: 38282880
• Report Number: 2183502-2016-00211
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2020
• Device Model Number: 21-7230
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 75X163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1