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

Model Number	SET INFULIN 6MM/INSERTER/42 BUCKLE
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smith medical cleo infusion set had several malfunctions where it caused consumer to have complications associated with diabetes.First noted the spring did not work.Secondly ,the glue between the plastic tape and solid part of device was not sticking; after one hour separated.The report states listed above malfunctions caused her to have hyperglycemia and close monitoring of blood glucose levels,checking for ketones in urine, which subsequentially caused interventions of insulin sliding scale injections with aide from hospital nurse.One other occasion th tube separated from the adhesive.The consumer provided pictures of the malfunctions.No other long term adverse events reported.Hyperglycemia can cause diabetic ketoacidosis.Interventions were required to preclude serious injury for risk of kidney failure, heart and most common cerebral edema.Critical care would need to be implemented to stabilize the patient.
Additional Manufacturer Narrative
Three photos of smiths medical cleo 90 infusion set, product number 21-7222-4, lot number 3793908 were received for review.On the first picture, it was observed that the tube was separated from the buckle, on the second picture it was observed that the buckle was partially connected to the cannula site and the third picture was a top view of the cap of the product.A review of manufacturing processes was performed.It was verified that procedures in the assembly process and quality check process were being properly followed.The investigation determined that a possible, but unconfirmed cause of the reported tubing separation issue was that adhesive was missing during visual inspection.The spring issue was not confirmed as no samples were returned for evaluation.

• Brand Name: CADD CLEO INFUSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9325296
• Report Number: 3012307300-2019-05981
• Device Sequence Number: 18937210
• Product Code: FPA
• UDI-Device Identifier: 30610586028353
• UDI-Public: 30610586028353
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,user fac
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/30/2019
• Device Model Number: SET INFULIN 6MM/INSERTER/42 BUCKLE
• Device Catalogue Number: 21-7222-24
• Device Lot Number: 3793908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention