MAUDE Adverse Event Report: UNOMEDICAL A/S AUTOSOFT XC; UNO NERIA STEEL G29 80/08CM(10/200)INT

Model Number	78-080-2938
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final mdr (b)(4) - device 1 of 6.
Event or Problem Description
Reference number (b)(4).Event occurred in the united states on (b)(6) 2024, it was reported that the patient infusion set cannula is not in place for 6 events within 3 hours of insertion.The site of insertion was abdomen.Patient replaced infusion set and resumed insulin successfully.Do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.Has context menu no further information available.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Supplemental report 01 - (b)(4) - mdr 3003442380-2024-25431.Correction: this mdr is being submitted to correct the submitted common device name under d2, model number, serial number, primary unique device identifier (udi) number under d4.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: per revision 21 of procedure 3709030, a child investigation is not required to document the dhr review for a type 2 reportable complaint.However, the child was created to allow the parent record to advance to review and summary.Since it was created, the dhr review was documented within the child.Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6005464, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 6005464 was manufactured according to the work instruction (wi) version 96 and manufactured in the line m10 on 12-feb-2024, with a total of (b)(4) units.Review of 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.The sub-assembly: gluing of tubing lot 4b00690 was manufactured according to the work instruction (wi) version 60 and manufactured in the machine sc05-sc06, on 12-feb-2024, with a total of (b)(4) units.Review of 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 summary of complaint investigation: as a result of the following: no non conformance (nc) raised during production related to complaint code, no trend identified for the lot in question and malfunction code, no further actions are required.This complaint will not require further root cause investigation nor corrective and preventive action (capa) plan.Therefore, this issue will be monitored through the post market surveillance activities.

• Brand Name: AUTOSOFT XC
• Common Device Name: UNO NERIA STEEL G29 80/08CM(10/200)INT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 20357882
• Report Number: 3003442380-2024-25431
• Device Sequence Number: 12555464
• Product Code: FPA
• UDI-Device Identifier: 05705244000674
• UDI-Public: 05705244000674
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032854
• 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): 11/27/2025

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 Model Number: 78-080-2938
• Device Lot Number: 6005464
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female