MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 02/06/2020

Event Type  malfunction  

Event Description

Information was received indicating that at the end of therapy, part of a smiths medical cadd cleo infusion set broke off inside a pediatric patient.The reporter indicated that, the patient was scheduled for ultrasound and possibly surgery to remove the portion left inside.No further adverse events were reported.

Manufacturer Narrative

Information was received on 03/25/2020 indicating, it was noted that the event occurred upon removing the cannula from the lower back, plastic cannula broke off under skin and was deeply embedded.The patient had two ultrasound and will need surgical intervention to remove the embedded cannula.

• Brand Name: CADD CLEO INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9793456
• MDR Text Key: 182178432
• Report Number: 3012307300-2020-01730
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention