MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 42" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Product Quality Problem (1506)

Patient Problem Malaise (2359)

Event Date 11/06/2021

Event Type  Injury  

Event Description

Solicited call to patient's mother who reported that patient's site does not last any longer than 2-4 weeks.She spoke to the cvs field nurse about them and was advised that the patient might get sites that last longer if she doesn't use the cleo system.Her last site change was on (b)(6) 2021 and she wasn't feel well afterwards.Her doctor advised her to lower her pump rate for remodulin from maintenance rate of (b)(4) to (b)(4) and then to go back up when she is feeling better.She is feeling better now.No other information provided.Reported to cvs/caremark by pt/caregiver.

• Brand Name: INF SET CLEO 42" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12814525
• MDR Text Key: 280935918
• Report Number: MW5105320
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• 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 Age: 15 YR
• Patient Sex: Female