MAUDE Adverse Event Report: UNOMEDICAL A/S ACCU-CHEK ULTRFLEX INFUSION SET; UNO ULTRAFLEX I 60/8 DIDU

Model Number	04626583001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final mdr (b)(4).Device 2 of 4.E1: patient city: (b)(6).Patient country: brazil.
Event or Problem Description
Reference number (b)(4).Event occurred in brazil.It was reported that the patient faced four infusion set cannula were leaking events on (b)(6) 2024.The events occurred immediately after insertion.The insertion site was at the abdomen, legs and flanks.No further information was available.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Supplemental report 01 - mdr (b)(4).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: the information in this complaint (b)(4) has been evaluated.The batch 5408422 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with work instruction (wi) guideline for test of ref.Samples version 11 for the code leakage from infusion site (cannula base part/cannula) (specific cause not identified).Complaint investigations.Photo/sample was not provided.In order to test the product, the reference samples from the lot has been requested.The following test was performed: visual test according to with wi version 38 on reference samples, 10 samples out 10 samples passed the test.Functional test 1 according to with wi version 10 on reference samples, 10 samples out 10 samples passed the test.Functional test 2 according to with wi version 7 on reference samples, 10 samples out 10 samples passed the test.A batch record review was conducted resulting in the following: the lot 5408422 was manufactured according to the document (b)(4) version 42 on the packing process in the line multivac 07, on 18/dec/2022, with a total of (b)(4) units.Review of the device history record (dhr) showed that all relevant tests required during the related process had been fulfilled and met the requirements.Trending: a query was run in database against malfunction code leakage from infusion site (cannula base part/cannula) (specific cause not identified) and lot 5408422 and no other one complaint has been registered in database since the last 12 months.Conclusion summary of the related event: as a result of the following: harm no reportable, no defect on tests, no non-conformance (nc) raised during production, no other complaint received on the lot in question, no further actions are required.Therefore, this issue will be monitored through the post marketing survillence (pms) product trends and malfunction according to the on market quality review (omqr) procedure.

• Brand Name: ACCU-CHEK ULTRFLEX INFUSION SET
• Common Device Name: UNO ULTRAFLEX I 60/8 DIDU
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, ca 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 20804380
• Report Number: 3003442380-2024-32997
• Device Sequence Number: 9830775
• Product Code: FPA
• UDI-Device Identifier: 04015630049929
• UDI-Public: 04015630049929
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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 Expiration Date: 11/16/2025
• Device Model Number: 04626583001
• Device Lot Number: 5408422
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female