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

Device Problem Separation Failure (2547)

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

Event Date 12/01/2020

Event Type  malfunction  

Event Description

Per pt, a large majority of the inf set cleos that she received from us are not disconnecting from her sq site when she tries to change the tubing and therefore, she had to change her sq site 4 times in the month of december alone in order to change the tubing.No adverse events experienced due to defective product.Unknown if patient has defective product on hand for return.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: 11462695
• MDR Text Key: 239737782
• Report Number: MW5099935
• Device Sequence Number: 1
• Product Code: FPA
• 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: 01/04/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR