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
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the liquid does not come out of the syringe" there was no patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "occlusion - blockage/part stuck" was confirmed based upon the sample received.The customer returned one-unit mad100 mad nasal with 3 ml 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.The syringe was returned with the mad device.A functional inspection was performed on the returned device.The returned syringe was filled with water to test the atomization of the returned device.Upon testing, the device was not able to atomize properly.The water came out as a continuous stream.The device was sent to the manufacturing site for further analysis.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.A device history record review was performed with no evidence to suggest a manufacturing related cause.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" there was no patient harm or consequence.

• 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: 18668185
• Report Number: 3003898360-2024-00213
• Device Sequence Number: 15543228
• 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: 02/08/2024
• 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