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

Catalog Number 21-7220-24

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem Hyperglycemia (1905)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

Involved lot numbers reported by customer: 76x072, 75x079, and 76x114.Possible expiration date: 04/28/2021, 04/28/2020, 07/28/2016.Possible device manufacturer's date: 05/05/2016, 04/20/2015, 07/20/2016.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.(b)(4).

Event Description

It was reported that a cleo 90 infusion set cannula fell off or failed to stick properly.It was noted that the infusion set fell off immediately or after an hour.The cannula may have slid over while the tape was in place.The patient's blood glucose was known to rise.The blood glucose was brought down by replacing the infusion set and administering a manual shot.No permanent injury was reported.See mfr: 3012307300-2016-00409, 3012307300-2016-00410, 3012307300-2016-00411, 3012307300-2016-00412, 3012307300-2016-00413, 3012307300-2016-00414, 3012307300-2016-00415, 3012307300-2016-00416, 3012307300-2016-00417, 3012307300-2016-00418, 3012307300-2016-00419, 3012307300-2016-00420, 3012307300-2016-00422, 3012307300-2016-00423, 3012307300-2016-00424, 3012307300-2016-00425, 3012307300-2016-00426, 3012307300-2016-00427, 3012307300-2016-00428, 3012307300-2016-00429, 3012307300-2016-00430, and 3012307300-2016-00431.

• 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: 6140795
• MDR Text Key: 61306436
• Report Number: 3012307300-2016-00421
• 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,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Catalogue Number: 21-7220-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• 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: Initial
• Patient Sequence Number: 1
• Treatment: T-SLIM PUMP
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 25