MAUDE Adverse Event Report: ST PAUL CLEO; INFUSION SETS

Model Number SET, INSULIN, 9MM 24 BUCKLE

Device Problem Device Reprocessing Problem (1091)

Patient Problem Cellulitis (1768)

Event Date 02/02/2020

Event Type  Injury  

Event Description

Information received a consumer of a smiths medical cleo device experienced pain, inflammation and swelling at infusion site post completion of 3 days of infusion at the unknown site.Swollen (approx 7 cm in diameter).Inflamed and sore to the touch.Medication was prescribed to prevent spread of infection and worsening cellulitis.The site in use has been in place for three days, so the identification of cellulitis was not realized until rotating device.During that time the restart of infusion was placed at a different site.No further information on complication of the infection other then medication was prescribed to prevent further complication related to the cellulitis and it is described as staying localized.

• Brand Name: CLEO
• Type of Device: INFUSION SETS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10363475
• MDR Text Key: 201578625
• Report Number: 3012307300-2020-07789
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2023
• Device Model Number: SET, INSULIN, 9MM 24 BUCKLE
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 3675103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2018
• 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