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

Catalog Number 21-7230-24

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Erythema (1840); Hyperglycemia (1905); Pain (1994)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and 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 after the removal of the cleo® 90 infusion set "teflon tube", the patient was no longer able to see the bottom of the "base plate." according to the reporter, the patient suspected that the "teflon tubing" had broken during removal of the device and had remained in the subcutaneous adipose tissue.It was reported that the patient's blood glucose level was 316mg/dl immediately after removal of the infusion set; patient ketone levels were not checked and no leaking of insulin was observed.The patient reported pain and redness due to the event.The patient was reportedly in the emergency department and the physicians were unsure as to whether the "teflon tubing" remained in the skin and/or if the tubing could remain in the skin.The infusion set was in use for 2 days prior to the reported event.No permanent adverse effects to patient 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, bc 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6367883
• MDR Text Key: 68766864
• Report Number: 3012307300-2017-00578
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028397
• UDI-Public: 10610586028397
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 76X111
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2016
• 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