MAUDE Adverse Event Report: ST PAUL CADD CLEO INFUSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 90

Device Problem Separation Failure (2547)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Information received a smiths medical subcutaneous infusion systems|cadd cleo infusion sets left foreign body in patient body.The patients mother reported that there is a cleo 90 cannula that remained in the patient skin on left arm for almost 2 months now, after removing the infusion site.Patient mother doesn't recall the lot number of the cleo 90 and she has discarded the infusion site.Clarification is requested on the removal of device.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product was returned.We are unable to confirm the reported complaint.If the product is returned, will reopen this complaint for further investigation.

Event Description

Additional info received:the patient still has the cannula under the skin and no signs of infection has been reported when the mother was contacted.

• Brand Name: CADD CLEO INFUSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11872745
• MDR Text Key: 252262257
• Report Number: 3012307300-2021-04917
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention