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

Catalog Number 21-7220-24

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Skin Inflammation (2443)

Event Date 11/29/2019

Event Type  malfunction  

Event Description

Information was received that while a smiths medical cadd cleo infusion set was in use, several nodules in abdomen at periumbilical site appeared.The issue was reported to be ongoing.

Manufacturer Narrative

Additional information: b3, h10.Additional information received on that the reported issue was resolved.

• Brand Name: SMITHS MEDICAL CADD CLEO INFUSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 9762725
• MDR Text Key: 181144239
• Report Number: 3012307300-2020-01540
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028335
• UDI-Public: 10610586028335
• 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,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 3677257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1