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

Catalog Number 21-7230-24

Device Problems Bent (1059); Kinked (1339)

Patient Problem Hyperglycemia (1905)

Event Date 11/12/2016

Event Type  malfunction  

Manufacturer Narrative

Event date: reporter noted that event occurred in "the past two months" from date of report.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

It was reported that a cleo® 90 infusion set had a bent and kinked cannula.The patient's blood glucose was reported to be in the 400-500s (mg/dl).The patient reported she had large ketones and a healthcare professional identified the levels as dangerous/life-threatening.A manual injection was administered or a site change was conducted and a pump bolus was administered to address the high blood glucose.No third-party assistance was required to address the incident.The patient had been using infusion sets "for a while" and did not feel lumps under her skin where infusion sets were inserted.No permanent injury was reported.See mfr: 3012307300-2017-00351, 3012307300-2017-00352, 3012307300-2017-00353, 3012307300-2017-00354, 3012307300-2017-00355, and 3012307300-2017-00356.

• 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: 6323806
• MDR Text Key: 67318894
• Report Number: 3012307300-2017-00357
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7230-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 38 YR