MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF++SET CLEO24" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21723024

Device Problem Break (1069)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 05/01/2022

Event Type  Injury  

Event Description

Per spontaneous email from (b)(6) nurse from (b)(6) 2022: "patient texted at 6:28pm requesting nurse to call her.Once called, patient stated that she had to change her cleo{tubing) site due to pain and when she removed the old site the cannula was broken off.Nurse utilized face time to examine the removed cleo site with patient.The removed cleo site did appear to be broken at the tip.Advised patient to take removed cleo with her to the er.Patient reported previous site was painful and she felt that it might be infected." no further information provided.No other side effects reported.Lot number for tubing not provided.Author is not notifying md.It is not confirmed if patient went to the er per instructions.Reported to (b)(6) /caremark by health professional.

• Brand Name: INF++SET CLEO24" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 14513988
• MDR Text Key: 292817782
• Report Number: MW5109925
• 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: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 21723024
• Device Lot Number: 21723024
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female