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

Catalog Number 21-7230-24

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cellulitis (1768)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

It was reported that cellulitis was found at infusion site upper quadrant abdomen.No medical or surgical intervention was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No problems or issues were identified during this device history record review.E4: initial reporter also sent report to fda is unknown.

• 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 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16894256
• MDR Text Key: 314811070
• Report Number: 3012307300-2023-05384
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 3926571
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1