MAUDE Adverse Event Report: TELEFLEX MEDICAL MAD NASAL WITH 3 ML SYRINGE; NEBULIZER, MEDICINAL, NON-VENT

Model Number	IPN915303
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) failure mode "missing data on the packaging" 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.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 model and lot data on the packaging.The issue was identified at incoming inspection.".
Additional Manufacturer Narrative
(b)(4).The reported issue 'missing data on the packaging' was confirmed upon investigation of the returned sample.The customer provided one photo and returned one-unit mad100 mad nasal with 3 ml syringe for investigation.Visual inspection of the sample confirmed that the packaging is missing part of the labeling that includes the lot information.A device history record review was performed, and no relevant findings were identified.Based on the investigation of the returned complaint device, the root cause was identified to be a manufacturing issue related to not purging and scraping all the blank (unprinted) pouches.Corrective actions were previously implemented to address this issue.The returned sample was manufactured prior to the implementation of the corrective actions.
Event or Problem Description
It was reported that " missing model and lot data on the packaging.The issue was identified at incoming inspection.".

• Brand Name: MAD NASAL WITH 3 ML SYRINGE
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23449117
• Report Number: 3003898360-2025-00803
• Device Sequence Number: 15472325
• Product Code: CCQ
• UDI-Device Identifier: 14026704709813
• UDI-Public: (01)14026704709813(11)250114(17)280114(10)73A2500446(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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: 73A2500446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown