MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. CLEO 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Material Fragmentation (1261)

Patient Problems Cellulitis (1768); Foreign Body In Patient (2687)

Event Date 10/07/2019

Event Type  malfunction  

Event Description

Information was received indicating that upon removing a smiths medical cleo® 90 infusion set the end was observed to break off.The patient squeezed the site to try to remove the remaining cannula, but brown liquid came out.The patient reported that they saw their physician, an ultrasound was performed, and antibiotics were prescribed.There were no further reported adverse effects.

Manufacturer Narrative

Evaluation results: one cadd cleo infusion set was returned for investigation in used condition.The device was visually inspected, at a distance of 12 to 24 inches and under normal conditions of illumination.The investigator noted that the end of cannula was broken off, and the retractor was activated.The device did not undergo functional testing because any attempt to reprocess the device for subsequent re-use may adversely affect the integrity of the device or lead to deterioration in performance.A root cause could not be determined because the retractor was activated.The customer reported product problem could not be confirmed.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The problem source of the reported product problem was unknown.

• Brand Name: CLEO 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9577849
• MDR Text Key: 174683272
• Report Number: 3012307300-2020-00338
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention