MAUDE Adverse Event Report: Unomedical Devices S.A de C.V Inset II; Set, Administration, Intravascular

Model Number	MMT-921A
Medical Device Problem Codes	Partial Blockage (1065); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had high blood glucose because of crimped cannula and treated with iv infusion on (b)(6) 2023.
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.Imdrf cause investigation code: code b24 is not available in database to capture event history log review additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary e1: name: (b)(6) complaint investigation results: electronic quality management system (eqms) search: a query was run in the eqms on 24/jun/2026 against lot number 5393157 and similar malfunction codes: soft cannula found bent upon removal from infusion site, soft cannula found crimped upon removal from infusion site, i soft cannula and introducer needle found bent/kinked during insertion, unable to use, soft cannula found kinked upon removal from infusion site, soft cannula bent/kinked/crimped after removal -blockage.The review confirmed that lot 5393157 and the identified failure mode are not associated with any ncrs or capas of the same or similar nature.Similar complaints search: a query was run in the eqms on 24/jun/2026 against lot number criteria equal 5393157 and similar malfunction codes: soft cannula found bent upon removal from infusion site, soft cannula found crimped upon removal from infusion site, soft cannula and introducer needle found bent/kinked during insertion, unable to use, soft cannula found kinked upon removal from infusion site, soft cannula bent/kinked/crimped after removal -blockage.The count of complaints is 1.The complaint number is: complaint 1687888.Device history record (dhr) review: the lot 5393157 was manufactured according to work instruction (wi) version 58 and manufactured in the inset line05, on 05/sep/2022 with a total of (b)(6) units.Review of the dhr showed that during the outgoing test 6 an extended was found with short tube in the infusion set in one sample in lot 5393157 and therefore the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation was identified, nor maintenance events were recorded related to complaint code conclusion: dhr review supports compliance with manufacturing and quality requirements; no issues noted.Visual evidence review: no photo was provided to support visual confirmation of the reported issue.Conclusion: unable to perform visual verification; assessment based on available documentation only.Retain samples testing - does not confirm issue: retain samples from the relevant lot were requested and tested in accordance with approved procedures: work instruction (wi) - guidance for visual testing for complaints area (3.0): all 3 samples tested passed visual inspection.Work instruction (wi) - guidance for functional testing for complaints area (2.0): all 3 samples tested passed functional testing for the reported malfunction code: soft cannula bent/kinked/crimped after removal -blockage all test results were within specification as documented in the attached test report complaint (b)(4).Pdf conclusion: testing did not confirm the reported issue; no nonconformance identified.Return samples testing - sample not available: returned sample(s) from the relevant lot were requested; however, the customer confirmed that the sample is not available for return.Conclusion: visual and functional testing could not be performed due to lack of sample availability.Assessment will be based on other available evidence.Capa determination assessment - conclusion summary of complaint investigation: based on the investigation, no further investigation is required.The record will be closed and monitored through tracking and trending per work instruction (wi) (monthly trips and alerts).Complaint unconfirmed: following investigation, the reported failure could not be confirmed for this complaint.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: Inset II
• 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: pamela meadows ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; +1(603)247-0255
• MDR Report Key: 50031773
• Report Number: 3003442380-2026-57147
• Device Sequence Number: 9788335
• Product Code: FPA
• UDI-Device Identifier: 05705244019911
• UDI-Public: 05705244019911
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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: 08/04/2025
• Device Model Number: MMT-921A
• Device Lot Number: 5393157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown