MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 24" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Product Quality Problem (1506); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Patient reports this has been their fourth site change this year, was having a hard time with the adhesive on the cleo sticking.Patient stated that fluid gets under the adhesive, which then requires site change.No issues with current site, last site change 01/30/2023.Patient is using duoderm, cleo, and iv 3000 with current site and it is working well so far.No side effects reported.No further information available.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual product available for investigation? no; did we [mfr] replace the product? yes; did the pt have a backup product they were able to switch to? yes; was the pt able to successfully continue their therapy? yes; is the therapy life sustaining? yes.Reported to (b)(6) by pt/caregiver.Ref report: mw5115180, mw5115181.

• Brand Name: INF SET CLEO 24" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16442940
• MDR Text Key: 310417164
• Report Number: MW5115179
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female