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

Catalog Number 21-7230-24

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Bacterial Infection (1735); Inflammation (1932)

Event Date 10/06/2020

Event Type  malfunction  

Event Description

Information was received a patient had panniculitis and deep abscess infection with staph aureus while using a smiths medical cadd cleo infusion set.

Manufacturer Narrative

Other, other text: additional information received via (email) on 13 may 2021 we provided the incorrect lot number for complaint (b)(4).Originally it was thought that the impact lot was 3900361, however during our investigation it was determined that the impact lot was 3900357.

• Brand Name: CLEO 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: 11477978
• MDR Text Key: 239662993
• Report Number: 3012307300-2021-02039
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028397
• UDI-Public: 10610586028397
• Combination Product (y/n): N
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 3900357
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention