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

Catalog Number 21-7220-242

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 05/02/2018

Event Type  Injury  

Event Description

Information was received indicating that this subcutaneous infusion system was not working as expected and that the cannula may have bent shortly after insertion.It was noted that the patient's blood glucose level was 400mg/dl at the time of the event.It was unknown if intervention was taken.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information was received indicating the patient was able to change out their supplies (cartridge, infusion set, and site) and their blood sugars went down.No adverse patient effects were 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 MANUFACTURING S.A. DE C.V.; a d no.4; parque industrial internaciona; tijuana, bc ; MX
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; bc, MN 55442 ; 7633833310
• MDR Report Key: 7637577
• MDR Text Key: 112309812
• Report Number: 3012307300-2018-02544
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028339
• UDI-Public: 30610586028339
• 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: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/13/2022
• Device Catalogue Number: 21-7220-242
• Device Lot Number: 77X083
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR