MAUDE Adverse Event Report: ST PAUL CLEO 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7040-24
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.One (1) sample was received without its original packaging inside a ziploc bag and with its certificate of safe handling.The sample was visually inspected at a distance of 12 inches to 24 inches? and normal conditions of illumination.The technician observed that the adapter tube and coiled tube were detached.The complaint was confirmed.The root cause was found to be lack of solvent by not following procedures.Awareness notification was made to production personnel to explain the importance to adherence or following the procedure.No product information has been provided to date.(b)(4).
Event or Problem Description
It was reported that the medical device failed and medication did not come out.No patient injury was reported.

• Brand Name: CLEO 90 INFUSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; ofc 518; minneapolis, MN 55442
• MDR Report Key: 15337359
• Report Number: 3012307300-2022-17321
• Device Sequence Number: 20564730
• Product Code: FPA
• UDI-Device Identifier: 10610586020223
• UDI-Public: 10610586020223
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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 Expiration Date: 04/25/2024
• Device Model Number: 21-7040-24
• Device Catalogue Number: 21-7040-24
• Device Lot Number: 3788326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown