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

Catalog Number 21-7231-24

Device Problem Material Fragmentation (1261)

Patient Problems Hyperglycemia (1905); Device Embedded In Tissue or Plaque (3165)

Event Date 07/24/2017

Event Type  Injury  

Event Description

It was reported that the cannula of a cleo® 90 infusion set "stuck" in the patient's body.The patient blood glucose levels were 289mg/dl at the time of the event.To address the high blood glucose levels, the patient administered a bolus after changing the site.The patient did not test for ketones.The patient did not seek medical attention for the cannula remaining in the skin.No permanent injury was reported.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6788473
• MDR Text Key: 82491876
• Report Number: 3012307300-2017-01787
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028403
• UDI-Public: 10610586028403
• 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,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/24/2022
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 77X010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOVOLOG INSULIN
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 79