MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CLEO - SET, INSULIN, 9MM INSERTER/RETRACTOR, 24" BUCKLE AY; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7230-24
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date "middle of march 2024" initial reporter phone (b)(6).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 information becomes available.
Event or Problem Description
It was reported that during use, the catheter tube detached from the catheter.There was no physical exertion.The pump did not give an alarm and the patient¿s blood sugar levels rose to over 400mg/dl.
Additional Manufacturer Narrative
Three components of the sample were received for evaluation.No complete cleo sets were received, only parts of the assembly.Visual inspection found no discrepancies.The sample shows signs of manipulation and remanent of adhesive and tube; therefore, it cannot be confirmed that the failure mode reported in the complaint was generated during the manufacturing process.In conclusion, the failure mode was confirmed.The cause was unable to be established.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CLEO - SET, INSULIN, 9MM INSERTER/RETRACTOR, 24" BUCKLE AY
• 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: 19235006
• Report Number: 9617604-2024-00377
• Device Sequence Number: 6892263
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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 Catalogue Number: 21-7230-24
• Device Lot Number: 4334175
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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