MAUDE Adverse Event Report: UNOMEDICAL A/S UNO QUICK-SET 110/9 SC1 2-PACK MUL

Model Number	MMT-396AT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: since no lot number is available, a detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through pms product trends and malfunction.If any trends picked up, this will flag on the trips and alerts according to the omqr procedure.E1: patient city: (b)(6).Patient country: united states.
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.This mdr is being submitted for an unknown number of devices in which the issue was experienced.On 11-jul-2024, reported that patient faced infusion set crimped.Insertion site was below the belt line.Infusion set has been used for 2 days.Company 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.No further information available.
Event or Problem Description
To date, additional patient or event details were received which have been added in h11.
Additional Manufacturer Narrative
Additional information - this mdr is being submitted to include the below: d9: device available for evaluation has been selected as yes & date returned to mfg was added as well.H6: investigation results under type of investigation, investigation findings, investigation conclusions.

• Brand Name: UNO QUICK-SET 110/9 SC1 2-PACK MUL
• Common Device Name: UNO QUICK-SET 110/9 SC1 2-PACK MUL
• 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: 20072785
• Report Number: 3003442380-2024-22685
• Device Sequence Number: 6507712
• Product Code: FPA
• UDI-Device Identifier: 05705244024960
• UDI-Public: 05705244024960
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: MMT-396AT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native