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

Catalog Number 21-7221-24

Device Problems Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889)

Patient Problem Hyperglycemia (1905)

Event Date 09/04/2020

Event Type  malfunction  

Event Description

Information was received that the cadd cleo infusion sets did not deliver the insulin.The cannula of the catheter was reportedly kinked during pricking.Patient experienced very high blood sugar at 566 mg, high proportions of ketones, shortness of breath and other physical complications.Patient was able to reduce their blood sugar without external/medical help because they had an insulin pen they used.Customer has since been using a different lot and reportedly no longer experiences this event.

Manufacturer Narrative

Device evaluation: three used samples were returned for evaluation.The devices were inspected and no discrepancies were found.The devices were given functional testing; the devices were found to allow fluid through with no leakage detected.The reported issue was not confirmed during testing of samples.During production, this device type is sampled at regular intervals to ensure needle is properly threaded on the retractor assemblies.In addition, the devices are sampled for occlusion testing.

• Brand Name: CLEO
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10727789
• MDR Text Key: 212765583
• Report Number: 3012307300-2020-10567
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028342
• UDI-Public: 10610586028342
• Combination Product (y/n): N
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7221-24
• Device Lot Number: 3939064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other