MAUDE Adverse Event Report: UNOMEDICAL A/S CONTACT DETACH; UNO CONTACT DETACH G29 60/10 SC1 MIMX

Model Number	MMT-884A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	07/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: poland.
Event or Problem Description
Reference number (b)(4).Event occurred in poland it was reported that the patient faced the infusion set needle fracture issue on (b)(6) 2025.The patient was hospitalized due to needle fractured while in the body.The set insertion location was buttock.The patient was administered insulin in the hospital via pump.The patient was in the hospital for less than 24 hours.No further information available.
Additional Manufacturer Narrative
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.Complaint investigation results: a complaint investigation has been initiated to review the device history record (dhr) associated with the reported issue.The batch 6011309 in question was manufactured at the reynosa site.Dhr review: the lot 6011309 was manufactured according to the work instruction (wi) version 99 and packaging in the multivac 14, on 27-jan-2025, with a total of (b)(4) units.The sub-assembly, welding: the lot 4k05783 was manufactured according to the wi version 34 welding in the machine ls06, ls07 on 27/jan/2025, with a total of (b)(4) units.The sub-assembly, gluing of tubing: the lot 5a05906 was manufactured according to the wi version 66 in the gluing of tubing in the line ft02, on 26/jan/2025, with a total of (b)(4) units.The lot 5a02606 was manufactured according to the wi version 66 in the gluing of tubing in the line ft02, on 30/jan/2025, with a total of (b)(4) units.The sub-assembly, gluing of connector: the lot 5a03996 was manufactured according to the wi version 37 in the gluing of connector in the line 03, on 27/jan/2025, with a total of (b)(4) units.The sub-assembly, moulding: the lot 5a05902 was manufactured according to the wi version 36 in the moulding in the line ls19 on 27/jan/2025, 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.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: CONTACT DETACH
• Common Device Name: UNO CONTACT DETACH G29 60/10 SC1 MIMX
• Manufacturer (Section D): UNOMEDICAL A/S; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 23601416
• Report Number: 3003442380-2025-16803
• Device Sequence Number: 9712050
• Product Code: FPA
• UDI-Device Identifier: 05705244019430
• UDI-Public: 05705244019430
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041545
• 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): 11/26/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-884A
• Device Lot Number: 6011309
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown