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

Catalog Number 21-7221-24

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

It was initially reported as (b)(6) 2013 and it was then reported that the event occurred "over a 2 year span" lot number: potential lot number 76x116.Potential expiration date: 07/28/2021.Potential device manufacturer date: 07/20/2016.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.Mfr# clarification: new registration number (b)(4), ((b)(4)) is now being used for mfr report number, replacing registration number b)(4), ((b)(4)).

Event Description

It was reported that a cleo 90 infusion set caused irritation at the infusion site after two days.The patient noted that she had (b)(6) and may have contributed to the reported issue.The patient's blood glucose was reported to be at 500mg/dl.Multiple daily insulin injections were used to correct the high blood glucose.No permanent injury was reported.See mfr: 3012307300-2016-00339, 3012307300-2016-00340, 3012307300-2016-00341, 3012307300-2016-00342, and 3012307300-2016-00343.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, 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, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6103330
• MDR Text Key: 59940452
• Report Number: 3012307300-2016-00344
• 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
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7221-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2016
• 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