MAUDE Adverse Event Report: TELEFLEX MEDICAL MAD NASAL INTRANASAL MUCOSAL ATOMIZATION; NEBULIZER, MEDICINAL, NON-VENT

Model Number	IPN915303
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "foreign material in the primary packaging.The issue was identified during incoming inspection.There was no patient involvement.".
Additional Manufacturer Narrative
(b)(4) failure mode "foreign material loose in package" could be confirmed with picture attached.However, it is necessary to receive the physical sample to perform a proper investigation, determinate the root cause & corrective actions.Per dhr the product mad nasal with 3 ml syringe lot # 73d2400927 was manufactured on 04/25/2024 a total of (b)(4) pieces.Lot was released on 05/10/2024.Dhr investigation did not show issues related to complaint.If the complaint samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
It was reported that "foreign material in the primary packaging.The issue was identified during incoming inspection.There was no patient involvement.".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one-unit mad100 mad nasal with 3 ml syringe for investigation.The sample was returned sealed in its original packaging.Visual examination of the returned sample revealed that there was a small piece of foreign material loose in the package.It could not be determined what the foreign material was at the time of investigation.The packaging was confirmed to be completely sealed.Dimensional inspection was performed on the foreign material.A tappi chart was used to measure the size of the foreign material.The foreign material was found to be 0.40 sq mm.Per manufacturing procedure, foreign material should be no "bigger than 0.6 sq mm".Therefore, the foreign material is within the acceptable tolerance.Dhr investigation did not show issues related to complaint.Manufacturing procedure was inspected to review the allowable size for foreign material within the device packaging.The reported complaint of "foreign material loose in package" was confirmed based upon the sample received.The sample was received in its original packaging completely sealed.Visual inspection confirmed that there was a piece of foreign material in the package.Per manufacturing procedure, foreign material should be no "bigger than 0.6 sq mm".The foreign material was found to be within the acceptable tolerance.Teleflex will continue to monitor and trend on this issue.

• Brand Name: MAD NASAL INTRANASAL MUCOSAL ATOMIZATION
• 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: 21534361
• Report Number: 3003898360-2025-00199
• Device Sequence Number: 7055356
• Product Code: CCQ
• UDI-Device Identifier: 14026704709813
• UDI-Public: (01)14026704709813(11)240425(17)270424(10)73D2400927(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 73D2400927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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
• Patient Sex: Unknown