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	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: 3003898360-2024-00212.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint of "broken/detached parts - cracked/torn" was confirmed based upon the sample received.Visual examination of the returned device revealed that the nasal plug and distal tip were detached from the lumen tube.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.The device was sent to the manufacturing site for further analysis.The manufacturing site inspected the device and found no issues with the application of the adhesive on the distal end of the device that would cause the distal tip to detach from the lumen tube.There was no evidence to suggest a manufacturing related root cause for this issue.Therefore, the root cause is related to unintentional user error.Teleflex will continue to monitor and trend on complaints of this nature.
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: 18667258
• Report Number: 3003898360-2024-00211
• Device Sequence Number: 8331955
• 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: 03/20/2024
• 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
• Patient Sex: Unknown