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

Catalog Number 004192

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2016

Event Type  Injury  

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

The customer reported adhesive not separating from the cleo 90 6mm 23" infusion set while attempting insertion.Patients' blood glucose was checked and reported at 209mg/dl.Patient corrected level with a pump bolus of humalog.Unknown patient's condition at this time.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 1265 grey fox rd; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 1265 grey fox rd; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5762538
• MDR Text Key: 48583138
• Report Number: 2183502-2016-01300
• Device Sequence Number: 1
• Product Code: FPA
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Catalogue Number: 004192
• Device Lot Number: 75X140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR