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

Model Number	21-7232-24
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had pain from her groin to her right breast as well as site pain in her right infusion site.She states she removed the infusion device, but the cannula remained in her skin.She states the pain from her groin to her right breast has resolved but her site pain, although better, is still painful.No medical or surgical intervention was reported.
Additional Manufacturer Narrative
History record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.Samples were received for evaluation from were received in unused condition within their original package and one sample was received in used conditions without its original package.Visual inspection: the samples were visually inspected, at a distance of 12 inches to 24 inches and normal conditions of illumination.Result: cannula broken was found in sample in used condition.The retractor assemblies are 100 percent visually inspected by the production personnel to assure that the needle is properly threaded.Quality check performs an in-process audit at 1-hour intervals to verify that needle is properly threaded on the retractor assemblies.In order to perform a complete root cause analysis of this failure mode, a corrective action was opened.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: CLEO
• Common Device Name: 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: 15464828
• Report Number: 3012307300-2022-20094
• Device Sequence Number: 20557090
• Product Code: FPA
• UDI-Device Identifier: 30610586028414
• UDI-Public: 30610586028414
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2024
• Device Model Number: 21-7232-24
• Device Catalogue Number: 21-7232-24
• Device Lot Number: 3788300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown