MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CLEO INSULIN SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7231-24
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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 the insertion aid could only be removed with the help of another person and this occasionally bent the tube and led to the error messages during insulin release.The message ¿tube blocked¿ appeared although 20 units were still included.The issue occurred immediately upon use.There was no harm/adverse event reported.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: one sample was received.As received, the cannula tubing was observed to be deformed.No other damages or anomalies were observed.The complaint of cannula breakage can be confirmed.The complaint of strong adhesion cannot be confirmed nor replicated.The complaint of pump occlusion cannot be confirmed nor replicated due to the catheter and pump not being returned for a full comprehensive evaluation.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: CLEO INSULIN SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21269882
• Report Number: 3012307300-2025-01318
• Device Sequence Number: 15492998
• Product Code: FPA
• UDI-Device Identifier: 30610586028407
• UDI-Public: (01)30610586028407(17)270908(10)4321046
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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 Catalogue Number: 21-7231-24
• Device Lot Number: 4321046
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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