MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 004197

Device Problem Sticking (1597)

Patient Problem Hyperglycemia (1905)

Event Date 07/21/2016

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

Customer reported cleo 90 infusion sets fell off due to being stuck to the cap before opening the site.This report represents the first of two infusion sets affected by this issue on the given date of event.Blood glucose was adversely affected and reported to be at 400mg/dl.The site was changed and a bolus was delivered to address the high blood glucose.No injury was reported.Please note the following medwatch forms are related: 2183502-2016-01796, 2183502-2016-01797, 2183502-2016-01804, 2183502-2016-01805, 2183502-2016-01806, 2183502-2016-01807, 2183502-2016-01808, and 2183502-2016-01809.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 51122 ; 7633833074
• MDR Report Key: 5897265
• MDR Text Key: 52831851
• Report Number: 2183502-2016-01797
• 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,distributor
• Reporter Occupation: Other
• 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: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 004197
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR