MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC INF SET CLEO 31''6MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Improper Flow or Infusion (2954)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Outbound call to pt's mom.Pt's mom reports pt is currently in the hospital.Per mom, patient was just sent to the hospital/rehab a little over a week ago with no discharge date yet.When i asked reason for hospitalization, she said it was because they want the family to have more training before sending the p home.No further information provided.Also made outbound call and spoke with hospital pharmacist, (b)(6) who reported that patient just changed their sq site yesterday due to previous site being occluded no other information was provided regarding the old site.She states no problems with newly placed site all known information is contained in this report.Reported to (b)(6) by: patient/caregiver.

• Brand Name: INF SET CLEO 31''6MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC
• MDR Report Key: 15886047
• MDR Text Key: 304633004
• Report Number: MW5113534
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female