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

Catalog Number	21-7232-24
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that, during the change of the site, the catheter remained in the injection site.No patient injury reported.
Additional Manufacturer Narrative
Two samples were received for evaluation.The samples were received in unused condition; no damage or dysfunctional conditions were observed on the cannula.Visual inspection revealed the samples were without their original packaging and decontaminated.Unit one arrived in used condition without the cannula and with the adhesive used.Unit two arrived in unused condition; no damage or dysfunctional conditions were observed on the cannula.Functional testing was performed but the reported issue could not be replicated.No root cause could be determined as no device problem was found.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No actions were taken.Email address: (b)(6).

• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16598339
• Report Number: 3012307300-2023-02834
• Device Sequence Number: 14780142
• Product Code: FPA
• UDI-Device Identifier: 10610586028410
• UDI-Public: 10610586028410
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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: Lay User/Patient
• Device Expiration Date: 02/11/2025
• Device Catalogue Number: 21-7232-24
• Device Lot Number: 3941148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown