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

Model Number	21-7232-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2020
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.Product samples were received for evaluation.Visual and functional testing were performed.No discrepancies were observed during visual inspection and during functional testing of the received canula, the water passed through the connector and no leaks were observed in the assembly.The reported issue could not be confirmed.The root cause cannot be established as no fault was found.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that there was a leakage at the catheter-tubing connection during the delivery of the medication.Installation sites were changed regularly.The patient had blockages because of this leakage.The lot number of the infusion set has been changed and the issue has since resolved.No patient injury was reported.

• Brand Name: CLEO 90 INFUSION SET
• 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: 15395060
• Report Number: 3012307300-2022-18364
• Device Sequence Number: 20097850
• Product Code: FPA
• UDI-Device Identifier: 30610586028414
• UDI-Public: 30610586028414
• Combination Product (Y/N): N
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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: 02/07/2023
• Device Model Number: 21-7232-24
• Device Catalogue Number: 21-7232-24
• Device Lot Number: 78X023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2018
• 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 Age: 53 YR
• Patient Sex: Female