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

Catalog Number 004192

Device Problem Partial Blockage (1065)

Patient Problem Hyperglycemia (1905)

Event Date 07/15/2017

Event Type  Injury  

Event Description

It was reported that the patient could not see drops after filling the tubing of a cleo® 90 infusion set.The patient did not notice any damage to the device when the product packaging was first opened.The patient could not get drops to come from the end of the tubing during troubleshooting with the distributor.The patient's blood glucose levels were 210mg/dl at the time of the event.To address the high blood glucose levels, the patient changed the tubing.The patient was able to successfully fill the tubing and observed drops coming from the end of the tubing.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 Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6776933
• MDR Text Key: 82145733
• Report Number: 3012307300-2017-01699
• 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
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2019
• Device Catalogue Number: 004192
• Device Lot Number: 74X259
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2019
• 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
• Treatment: HUMALOG INSULIN
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR