MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG CLEO® 90 INFUSION SET; SUBCUTANEOUS INFUSION SET

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Hyperglycemia (1905); Device Embedded In Tissue or Plaque (3165)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

Additional 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

It was reported that the cleo catheter stayed in the patient when making a change.The patient presented to a hospital which showed the detached part was still in her body.This caused high blood sugars.An ultrasound was performed, but the cannula was not found.The patient received insulin and was released.A new cleo set was then utilized.Information regarding the outcome was requested, if received, a follow up report will be sent.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a.dec.v. ave, calidad no. 4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a.dec.v. ave, calidad no. 4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 1265 grey fox road; st paul 55112 ; 7633833074
• MDR Report Key: 5784291
• MDR Text Key: 49231208
• Report Number: 2183502-2016-01390
• 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,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 07/11/2016
• 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
• Patient Outcome(s): Required Intervention