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

Device Problems Bent (1059); Product Quality Problem (1506); Device Dislodged or Dislocated (2923)

Patient Problem Hyperglycemia (1905)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.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

It was reported that a cleo® 90 infusion set adhesive had issues and caused the cannula to become dislodged and bent.The patient's blood glucose levels were adversely affected and reported at greater than 399mg/dl.The patient changed the site and delivered correction bolus or administered an injection to address the high blood glucose.No permanent injury was reported.See mfr: 3012307300-2016-00016, 3012307300-2016-00017, 3012307300-2016-00028, 3012307300-2016-00029, 3012307300-2016-00030, 3012307300-2016-00031, 3012307300-2016-00033, 3012307300-2016-00034, 3012307300-2016-00035, 3012307300-2016-00036, 3012307300-2016-00037, 3012307300-2016-00038, 3012307300-2016-00039, 3012307300-2016-00040, 3012307300-2016-00041, 3012307300-2016-00042, 3012307300-2016-00043, 3012307300-2016-00044, and 3012307300-2016-00045.

• 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, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6017108
• MDR Text Key: 56994875
• Report Number: 3012307300-2016-00032
• 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,distributor
• Reporter Occupation: Other
• 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: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR