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

Catalog Number	21-7230-24
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cleo injection port had a small piece at the top of the central clear plastic that popped off easily when lifted by a fingernail.There was unknown patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
D4.Lot number, expiration date, and h4.Manufacture date are unknown; no information has been provided to date.D5.Other operator of device: operator of device is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
No lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.

• Brand Name: CLEO SUBQ DISPOSABLE 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: 18734645
• Report Number: 9617604-2024-00145
• Device Sequence Number: 15011335
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: Other
• Device Catalogue Number: 21-7230-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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