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

Model Number	IPN915303
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Failure mode "foreign material - stain" 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.If the complaint samples become available at a later date, this complaint will be updated accordingly.

• Brand Name: MAD NASAL INTRANASAL MUCOSAL ATOMIZER
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21898073
• Report Number: 3003898360-2025-00350
• Device Sequence Number: 3434825
• Product Code: CCQ
• UDI-Device Identifier: 14026704709813
• UDI-Public: (01)14026704709813(11)240806(17)270805(10)73G2401264(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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: 73G2401264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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.
• Patient Sex: Unknown