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

Catalog Number	21-7230-24
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device or device photo was returned for investigation.Functional and visual testing could not be performed and no confirmation due to no device returned.Due to this, no root cause was determined.The device history review of the reported lot number found no non-conformities during the manufacturing process.
Event or Problem Description
It was reported that the needle applicator did not stick to the skin and they had to put a new one on in the middle of the infusion.There was patient involvement, and no patient harm/adverse event reported.

• Brand Name: CLEO INSULIN INSERTER/RETRACTOR 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: 20388382
• Report Number: 3012307300-2024-10667
• Device Sequence Number: 15090371
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: (01)30610586028391(17)270723(10)4308584
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2024

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: Health Professional
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 4308584
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2022
• 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