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

Catalog Number 21-7230-24

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 07/18/2017

Event Type  Injury  

Event Description

It was reported that during a routine change of this cleo® 90 infusion set, the cannula of the device was found to be lodged beneath the skin.The patient's blood glucose levels were noted to be approximately 450 mg/dl at peak.The patient inserted a new site and successfully resumed infusion.Initially, the patient was advised by a healthcare professional to leave the cannula under the skin in anticipation that the body's inflammation response would release the cannula.This condition remained ongoing, and the patient was admitted to the hospital for surgical removal of the lodged cannula.Surgical intervention resolved the issue, and the patient was discharged three days later.The healthcare professional believed that the cause of this occurrence could be attributed to bacteria and an "unclean site." no other adverse patient effects were reported.

Event Description

It was additionally reported that the cannula remained in the patient's body and was scheduling surgical removal.The patient's blood glucose at 450mg/dl was resolved and returned to target levels.

• 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 MANUFACTURING S.A. DE C.V.; ave calidad no. 4; parque industrial internacion; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6794868
• MDR Text Key: 82704288
• Report Number: 3012307300-2017-01798
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028397
• UDI-Public: 10610586028397
• 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,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/11/2021
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 76X169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 20 YR