MAUDE Adverse Event Report: SMITHS MEDICAL INFUSION SET CLEO 31" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 77X-169

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/18/2018

Event Type  Injury  

Event Description

Patient had part of his cleo infusion set break off in his subcutaneous site.Patient's wife was able to retrieve the broken piece out of the site.Patient denies any adverse effects or signs of infection.Patient has disposed of broken cleo infusion set.Dates of use: (b)(6) 2018 to ongoing.Diagnosis or reason for use: i27.0.

• Brand Name: INFUSION SET CLEO 31" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 7369250
• MDR Text Key: 103550093
• Report Number: MW5076085
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 77X-169
• 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: 33 YR