MAUDE Adverse Event Report: UNOMEDICAL UM-D QUICK SET; UNO QUICK-SET 60/6 SC1 MCAN

Model Number	MMT-399A600
Medical Device Problem Codes	Infusion or Flow Problem (2964); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: (b)(6).
Event or Problem Description
Reference number (b)(4).Event occurred in canada.The patient reported experiencing a bent cannula event on (b)(6) 2026, which disrupted insulin delivery and resulted in hyperglycemia (18 mmol/l).The elevated blood glucose was successfully managed by the patient through self-administration of insulin via syringe, resolving the issue with no further complications.No further information available.

• Brand Name: QUICK SET
• Common Device Name: UNO QUICK-SET 60/6 SC1 MCAN
• Manufacturer (Section D): UNOMEDICAL UM-D; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p, 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 24741305
• Report Number: 3003442380-2026-05965
• Device Sequence Number: 8704252
• Product Code: FPA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: MMT-399A600
• Device Lot Number: 6009531
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown