MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 31" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21723124

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Spontaneous call from patient.Patient called and informed she has parts of the cleo infusion set stuck inside her from previous infusion sites, she stated this is the third time it occurred.She reached out to md office but was advised to reach out to (b)(6) specialty.There isn't any pain from the pieces stuck inside her, no bleeding or discharge from the scars.She was wondering of what can be done to prevent it from happening again.Advised i will have a nurse reach out to review insertion technique and/or review other infusion set options.Advised patient to monitor for signs of infection and inform md/(b)(6) immediately.No further information at this time.Reported to (b)(6) by pt/caregiver.

• Brand Name: INF SET CLEO 31" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 11723595
• MDR Text Key: 247565937
• Report Number: MW5100973
• Device Sequence Number: 3
• 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: 04/21/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21723124
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1