MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A DE C.V QUICK SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MMT-397A
Medical Device Problem Codes	Partial Blockage (1065); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number.Reporting site: 8021545.Manufacturing site: 3003442380.
Event or Problem Description
It was reported that the patient experienced pain at the insertion site on (b)(6) 2026 as the infusion set cannula was bent.The infusion set has been in use for two days.

• Brand Name: QUICK SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A DE C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer (Section G): UNOMEDICAL DEVICES S.A DE C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer Contact: courtney smith ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 6032470255
• MDR Report Key: 24975644
• Report Number: 3003442380-2026-09744
• Device Sequence Number: 18511635
• Product Code: FPA
• UDI-Device Identifier: 05705244006416
• UDI-Public: 05705244006416
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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
• Device Model Number: MMT-397A
• Device Lot Number: 6012429
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown