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

Model Number	MMT-397
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that patient has passed away due to an unknown reason on (b)(6) 2022.
Additional Manufacturer Narrative
Unomedical hereby submits this initial report as part of its complaint remediation activities conducted under a capa 2356421 and capa 2566479 in accordance with the fda action plan, which incorporates qp-ic-2026-0020 (ic retrospective complaint review) and qp-ic-2026-0024 (ic retrospective mdr review).This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this supplemental information in accordance with the reporting requirements set forth in 21 cfr part 803.Any fields left blank indicate that the information is unknown, unavailable, or remains unchanged.E1: patient city: (b)(6).Patient country: united states.Additional information - this medical device report (mdr) is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Complaint investigation results: a complaint investigation was performed based on the event description and the no malfunction based on complaint information.Lot number was provided; however, the evaluation of the event description did not identify evidence of device malfunction or product related failure.Based on the information available, the complaint is consistent with scenarios involving misuse, user-related factors, or no malfunction alleged, as reflected in the assigned malfunction code.In accordance with appendix 7.7 of work instructions complaint handling, the need for additional investigation activities, including batch record review, product testing, or eqms search, was evaluated and determined not to be warranted for this record.Corrective and preventive action (capa): based on the investigation, no further action is required.The record will be closed and monitored through tracking and trending per work instructions (monthly trips and alerts).Complaint investigation - conclusion: based on the event description and assigned malfunction code, the reported failure could not be confirmed for this complaint.Based on the available information, this event is deemed to be a reportable death.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.

• 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: 25481637
• Report Number: 3003442380-2026-31606
• Device Sequence Number: 10513214
• Product Code: FPA
• UDI-Device Identifier: 05705244006416
• UDI-Public: 05705244006416
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/03/2023
• Device Model Number: MMT-397
• Device Lot Number: 5317519
• 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: 05/20/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown