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

Catalog Number 004193

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and 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

The distributor reported on behalf of the product user explaining that the adhesive material became loose and resulted in the infusion set detaching from her skin.Product user reported that her blood glucose levels were not affected.No permanent serious injury was reported.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 1265 grey fox road; st paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 1265 grey fox road; st paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5467518
• MDR Text Key: 39269150
• Report Number: 2183502-2016-00344
• 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: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 004193
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• 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: N
• Patient Sequence Number: 1