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

Device Problem Difficult to Remove (1528)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Event Description

Pt report great difficulty in removing cleo when it's time to change the tubing.It often gets stuck and by the time the pt gets it off, his site will be very irritated.No other info available or reported.Reported to (b)(6) 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: 9877727
• MDR Text Key: 185051296
• Report Number: MW5093912
• 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: 03/09/2020

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2020
• Patient Sequence Number: 1