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	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned for evaluation.Quality review was attached.
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
Other text: additional information provided in h3, h6 and h10.This mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.No product sample was received; therefore, visual and functional testing could not be performed.Three photographs were received for evaluation.In the photos a detached tube was observed from the buckle / needle, as well as the lack of adhesive.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No corrective actions were taken for the reported issue since the complaint could not be confirmed due to the fact that no samples were received 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
• Manufacturer (Section G): NULL; 6000 lane n; minneapolis, mn
• Manufacturer Contact: dave halverson ; 6000 lane n; minneapolis, mn ; 3833310
• MDR Report Key: 10189838
• Report Number: 3012307300-2019-05983
• Device Sequence Number: 10971663
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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?: Yes
• 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown