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

Model Number	IPN915303
Medical Device Problem Codes	Complete Blockage (1094); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "cone of the nasal connector completely closed.Also, others from ve with the same production error.There was no patient involved." associated complaints 3003898360-2025-00029 and (b)(4).
Additional Manufacturer Narrative
(b)(4).From the pictures attached it was confirmed the defect reported by the customer "occlusion - blockage/part stuck".However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.A verification of failure mode reported in the current manufacturing process was conducted as follows: 80 samples were taken from the current production p/n mad100 mad nasal with 3 ml syringe, lot # 73l2400853, the samples were functionally inspected and issue reported as " occlusion - blockage/ part stuck" was not observed in the current manufacturing process.Device history record review was conducted on lot number 73k2300745, investigation did not show issues related to complaint.Failure mode "occlusion - blockage/part stuck" 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.Corrected data: section d.3 legal manufacturer updated from arrow to morrisville.
Event or Problem Description
It was reported that: "cone of the nasal connector completely closed.Also, others from ve with the same production error.There was no patient involved." associated complaints 3003898360-2025-00028, 3003898360-2025-00029 and (b)(4).

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21089121
• Report Number: 3003898360-2025-00028
• Device Sequence Number: 18308967
• Product Code: CCQ
• UDI-Device Identifier: 14026704709813
• UDI-Public: (01)14026704709813(11)231018(17)261017(10)73K2300745(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,Followup
• Report Date (Section B): 12/16/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: IPN915303
• Device Catalogue Number: MAD100
• Device Lot Number: 73K2300745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• 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
• Patient Sex: Unknown