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

Catalog Number 21-7220-24

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Cellulitis (1768); Swelling (2091); No Consequences Or Impact To Patient (2199)

Event Date 10/13/2019

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cleo 90 infusion set may have contributed to an infection at the patient's injection site.It was reported that there was difficulty attaching the cannula and that it was necessary to "re-do a few times before they could find a location where the needle would stick." per reporter it was at one of "these sites that the infection has started." it was reported that the patient experienced redness and swelling at the injection site; that it was hot to touch and tender.It was also reported that the patient experienced cellulitis and abscess in proximity to the device.Per reporter patient has recovered from cellulitis and concomitant medication and therapy was started.No additional adverse effects were reported.

Manufacturer Narrative

Additional information- reporter stated the issue occurred on (b)(6) 2019.Reporter stated the patient required hospitalization and needed medication to address the infection.Reporter confirmed the infection has since resolved.

• Brand Name: CLEO 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9416909
• MDR Text Key: 169259254
• Report Number: 3012307300-2019-06719
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028339
• UDI-Public: 30610586028339
• Combination Product (y/n): N
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 3677257
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention