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

Lot Number 2101928

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  Injury  

Event Description

Spontaneous email from (b)(6), nurse from doctor's office, who reported: "per patient her remodulin sites have only been lasting 2 weeks since she had to switch to the cleo insertion due to silhouette being discontinued." no other information provided.Unk if there is product problem with the pt's cleo tubing.Reported (b)(6) by health professional.

• Brand Name: INF SET CLEO 31" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 11715803
• MDR Text Key: 247217542
• Report Number: MW5100943
• 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: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 2101928
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1