MAUDE Adverse Event Report: TELEFLEX MEDICAL MAD NASAL INTRANASAL MUCOSAL ATOMIZATION; NEBULIZER, MEDICINAL, NON-VENT

Model Number	IPN915303
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "missing data on the primary packaging.The issue was identified during incoming inspection.There was no patient involved.".
Additional Manufacturer Narrative
(b)(4).Failure mode "labeling - incorrect or missing label" could be confirmed with picture attached.However it is necessary to receive the physical sample to perform a proper investigation, determinate the root cause & corrective actions.Per dhr the product mad nasal with 3 ml syringe lot # 73d2400927 was manufactured on 04/25/2024 a total of (b)(4) pieces.Lot was released on 05/10/2024.Dhr investigation did not show issues related to complaint.If the complaint samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
It was reported that "missing data on the primary packaging.The issue was identified during incoming inspection.There was no patient involved.".
Additional Manufacturer Narrative
(b)(4).The customer returned one-unit mad100 mad nasal with 3 ml syringe for investigation.The sample was returned sealed in its original packaging.Visual inspection of the sample confirmed that the packaging is missing part of the labeling that includes the lot information.Non-conformance has been initiated at the manufacturing site to further investigate this issue.Device history review investigation did not show issues related to complaint.The complaint is confirmed.Visual inspection of the sample confirmed that the packaging is missing part of the labelling that includes the lot information.Non-conformance has been initiated at the manufacturing site to further investigate this issue.

• Brand Name: MAD NASAL INTRANASAL MUCOSAL ATOMIZATION
• Common Device Name: NEBULIZER, MEDICINAL, NON-VENT
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21534489
• Report Number: 3003898360-2025-00205
• Device Sequence Number: 7857521
• Product Code: CCQ
• UDI-Device Identifier: 14026704709813
• UDI-Public: (01)14026704709813(11)240425(17)270424(10)73D2400927(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: Health Professional
• Device Model Number: IPN915303
• Device Catalogue Number: MAD100
• Device Lot Number: 73D2400927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown