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

Model Number 24" BUCKLE AY 10-10/BX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Fever (1858); Inflammation (1932); Pain (1994)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

Report source: foreign country: (b)(6).

Event Description

Information was received indicating that during use of this smiths medical cadd cleo infusion sets, the patient experienced feeling worse with fever and was admitted to the hospital.It was reported that the patient was diagnosed with cellulite and discharged with antibiotics.Furthermore, the patient complained about pain in the area of insertion, inflammation and erythema, as well as minimal suppuration prior to this event.Additional information received that the cellulites was treated with antibiotics and the outcome of the event was resolved.No additional adverse effects were reported.

Manufacturer Narrative

The product was not returned for analysis.To evaluate if there was an issue, 32 samples of p/n 21-7332-24 l/n 3919795 were taken from cleo production line and were visually inspected in order to verify that the spring is not released.No discrepancies were detected.Additionally, 4 samples from mentioned lot above were taken from production floor and tested according to pm-449 "cleo 90 in-process testing" using the insertion pad t98-5406 in order to identify any abnormal behavior on the transfer of the site to the pad.Again, no discrepancies were found.

• Brand Name: CADD CLEO INFUSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9765504
• MDR Text Key: 181434585
• Report Number: 3012307300-2020-01654
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• 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
• 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: 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 Model Number: 24" BUCKLE AY 10-10/BX
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 3675103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention