MAUDE Adverse Event Report: UNOMEDICAL A/S NERIA MULTI; UNO NERIA MULTI 60+30/8-3 (10/120) GLOB

Model Number	721060-2738
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in italy.It was reported that patient faced impurity inside the blister.No further information was available.
Event or Problem Description
To date no additional patient or event details have been received.
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: the information in this complaint (b)(4) has been evaluated.The batch 6004748 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with (work instructions) wi guideline for test of reference samples version 11 for the malfunction foreign matter (e.G., hairs, insects) within primary pack (blister pack).Complaint investigations: one photo has been received from the customer, and there is a visible black dot on the furcator inside of the blister.Therefore, a visual inspection on the individual packaging regarding to foreign particles was completed on ten reference samples of lot 6004748 and were found within specification, there are not any dot or extraneous particle.Relevant checks within the batch record related to the complaint issue foreign matter within primary pack were verified and no discrepancy was found during the batch record 6004748 review.The lot was sterilized and released, based on review of results of sterilization.A batch record review was conducted resulting in the following: - the lot 6004748 was manufactured according to the wi version 96 on the packing process in the multivac 09, on 13/jan/2024, with a total of (b)(4) units.- review of the device history report (dhr) was performed on 24/sep/2024 and showed that all relevant inspections on the foreign matter within primary pack were verified and no discrepancy were found.-the lot was sterilized and released, based on review of results of sterilization.A query was run in tw against malfunction and lot number 6004748 and no other complaint has been registered in tw since the last 12 months.Conclusion summary of the related event: as a result of the following: no samples have been returned, according to the investigation, no alleged failure related to the product can be confirmed.In the photos received, a black dot is visible on the blister and the size of the dot is acceptable, according to the acceptance criteria, if the foreign particle is attached to the blister and does not exceed the allowed size, the sample is within specifications, malfunction reported has been unconfirmed on the reference samples, no harm reported, no nc raised during production, no further actions are required.Therefore, this issue will be monitored through the pms product trends and malfunction according to the on market quality review (omqr).

• Brand Name: NERIA MULTI
• Common Device Name: UNO NERIA MULTI 60+30/8-3 (10/120) GLOB
• 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: 20407822
• Report Number: 3003442380-2024-28192
• Device Sequence Number: 6517915
• Product Code: FPA
• UDI-Device Identifier: 05705244002074
• UDI-Public: 05705244002074
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120395
• 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): 09/25/2024

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: 721060-2738
• Device Lot Number: 6004748
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2024
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native