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

Model Number	IPN048826
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the liquid does not come out of the syringe and the device cannot used.Moreover, the nasal adaptor broke".The patient was reported as fine post the procedure.Associated complaints 3003898360-2024-00211.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint of "occlusion - blockage/part stuck" was confirmed based upon the sample received.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.Visual examination of the returned device revealed that the nasal plug and distal tip were detached from the lumen tube.Although the device would be unable to function properly with the distal tip detached, an attempt to fire the device was made to see if anything was able to fire.The returned syringe was filled with water and then attached to the lumen tube to test for an occlusion of the returned device.Upon testing, the device was not able to fire any water.It appeared that there was an occlusion in the device.The manufacturing site inspected the device and found no issues with the positioning of the insert (component that helps with atomization).It could not be determined what prevented the device from atomizing properly at this time.The qa inspector performs a random atomization test in the press process during the manufacturing of this device to help identify this issue, if it occurs, at the time of manufacturing.Teleflex will continue to monitor and trend on this issue.
Event or Problem Description
It was reported that "the liquid does not come out of the syringe and the device cannot used.Moreover, the nasal adaptor broke".The patient was reported as fine post the procedure.Associated complaints 3003898360-2024-00211 and 3003898360-2024-00212.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18683373
• Report Number: 3003898360-2024-00212
• Device Sequence Number: 6509758
• Product Code: CCQ
• UDI-Device Identifier: 14026704613103
• UDI-Public: 14026704613103
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/12/2024

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 Expiration Date: 08/22/2025
• Device Model Number: IPN048826
• Device Catalogue Number: MAD100
• Device Lot Number: 73H2200671
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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