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

Model Number 21-7230-24

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Cellulitis (1768)

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The samples were visually inspected, at a distance of 12 to 24 and normal conditions of illumination.All the samples were received with the skin adhesive stuck on the white cap, one (1) sample was received without the base and cannula.The sample received with the base and cannula was tested using a buckle assembly taken from the production line to replicate the failure mode.No leaks were detected in the samples.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.The root cause of the reported event was found to be excessive voids in the static bond on the patch, which may be inherited in the raw material or created during conversion and/or assembly processes.Incoming lots are inspected and reword process are in place to ensure the patch lifted above 0.030 are reworked.A new inspection fixture was designed and developed to decrease that measurement variability to 0.005.The inspection fixture was improved under the procedure to accurately determine whether our product meets the 0.030 lift acceptance criteria.A new packaging configuration was implemented which the cleo devices are stored in a cap up orientation.A corrective and preventative action has been opened to address the reported issue.

Event Description

It was reported that a leakage has been observed under the adhesive part during the infusion; usually 1 hour or 2 hours after.The patient had redness in the insertion site.No medical or surgical intervention was reported.

• Brand Name: CLEO 90 SUBCUTANEOUS INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15666331
• MDR Text Key: 306727414
• Report Number: 3012307300-2022-26120
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: 21-7230-24
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 3586836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male