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

Model Number	IPN048826
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: l ( myo-inositol, purified water, sodium chloride), 10 drops of aircort (budesonide 0.5 mg; excipients: disodium edetate; sodium chloride; polysorbate 80; anhydrous citric acid; sodium citrate; water for injections), 3 drops of bactorinol (medical device in nose drops, containing lentisk oil).Qn#(b)(4).The actual sample was not returned; however, the customer provided a photo for evaluation.A visual exam was performed on the photo and the failure mode was confirmed.A device history record review was performed and no relevant findings were identified.Without the actual device to evaluate the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the patient was using the device at home and it broke during its first use.The patient completed their treatment by using another device.No medical intervention needed.No harm or injury to the patient.The patient condition is reported as "fine".

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16582305
• Report Number: 3003898360-2023-00421
• Device Sequence Number: 20007927
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2023

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: Lay User/Patient
• Device Expiration Date: 10/24/2025
• Device Model Number: IPN048826
• Device Catalogue Number: MAD100
• Device Lot Number: 73K2200838
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THE PATIENT WAS ADMINISTERING 1.5 ML OF BRONCOSITO
• Patient Sex: Unknown