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

Catalog Number 21-7220-24

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Hyperglycemia (1905)

Event Date 03/01/2018

Event Type  Injury  

Event Description

Information was received indicating that a smiths medical cleo® 90 infusion set was not adhering to the patient's skin; not sticking initially or falling off.Patient's mother reports that the "blood sugar was high" and insulin was required to manage blood sugar.No further adverse effects were reported.

Manufacturer Narrative

Six cleo infusion sets were returned for evaluation.Visual inspection found one received with retractor activated and skin adhesive stuck to the base.The other five samples were received with the retractor activated and the base removed.A functional test could not be performed due to the fact that the samples received for evaluation were previously used and according to instructions for use (aml40-5374-24j) any attempt to reprocess the device for subsequent re-use may adversely affect the integrity of the device or lead to deterioration in performance.No discrepancies were detected however.One (1) sample was place in "dry and clean skin" as per instructions for use.One (1) sample was placed on "greasy skin".One (1) sample was placed in "wet skin".The customer's complaint was not verified.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• 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 MEDICAL ASD, INC; 1265 grey fox rd; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7411415
• MDR Text Key: 104838976
• Report Number: 3012307300-2018-01033
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028339
• UDI-Public: 30610586028339
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 04/06/2022
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 77X052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 66