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

Catalog Number 21-7230-24

Device Problems Kinked (1339); Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2017

Event Type  malfunction  

Manufacturer Narrative

See mfr: 3012307300-2017-01769.

Event Description

It was reported that the patient experienced an occlusion alarm during use of a cleo® 90 infusion set.The patient tried changing the cartridge and site but the alarm repeated.It was noted that per the occlusion score card, the occlusion alarms likely were not false occlusions.Through troubleshooting, it was determined that there was a site issue contributing to the occlusion.The patient removed the site and observed the cannula was kinked at the tip.The patient's blood glucose levels were 150mg/dl at the time of the event.The patient inserted a new site and resumed insulin successfully.No permanent injury was reported.

• 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, 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6788398
• MDR Text Key: 82498078
• Report Number: 3012307300-2017-01770
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028397
• UDI-Public: 10610586028397
• 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: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/11/2021
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 76X169
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2016
• 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
• Treatment: NOVOLOG INSULIN
• Patient Age: 20 YR