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." associated complaints 3003898360-2025-00028,.And (b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).Legal manufacturer corrected for follow up.The customer returned one unit mad100 mad nasal with 3ml syringe for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appears typical.A functional inspection was performed on the returned device.The returned syringe was filled with water.Once reconnected to the mad device, only a small amount of water was able to be released when fired.However, the water came out in a continuous stream rather than aspirating.The sample was shipped to the manufacturing site for further evaluation.The manufacturing site confirmed that there is a slight obstruction in the device which prevents it from aspirating properly.The amount of force required to aspirate the device is unacceptable.Device history record review investigation did not show issues related to complaint.The reported complaint of "occlusion - blockage/part stuck" was confirmed based upon the sample received.The device was found to be partially occluded which prevented the device from aspirating properly.The amount of force required to aspirate the device is unacceptable.The root cause of this issue is manufacturing related.Non-conformance has been initiated to further investigate this complaint issue.
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 1900123838.

• 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: 21089103
• Report Number: 3003898360-2025-00029
• Device Sequence Number: 9155040
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN915303
• Device Catalogue Number: MAD100
• Device Lot Number: 73K2300745
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown