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

Model Number	IPN048826
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "stain on the primary packaging.The issue was identified at incoming inspection /inventory review.There was no patient involved.".
Event or Problem Description
It was reported that "stain on the primary packaging.The issue was identified at incoming inspection /inventory review.There was no patient involved.".
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 hardened piece of foreign material inside of the package.The manufacturing site was consulted for this investigation.Per the manufacturing site, the foreign material appears to be glue residue from the manufacturing line that got stuck inside the package.The packaging was confirmed to be completely sealed.Dimensional inspection was performed on the piece of foreign material.A tappi chart was used to measure the size of the foreign material.The piece of foreign material was found to be 1.00 sq mm.Non-conformance was previously initiated to further investigate this issue.Corrective actions were implemented to help prevent this issue from recurring.The returned sample was manufactured prior to the corrective actions being implemented.Device history record investigation did not show issues related to complaint.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 examination of the returned sample revealed that there was a piece of foreign material inside of the packaging.Per the manufacturing site, the foreign material appeared to be glue residue.Non-conformance was previously opened by the manufacturing site to further investigate this issue.Corrective actions were implemented.The returned sample was manufactured prior to the corrective actions being implemented.

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21512840
• Report Number: 3003898360-2025-00198
• Device Sequence Number: 12764171
• Product Code: CCQ
• UDI-Device Identifier: 14026704709813
• UDI-Public: (01)14026704709813(11)230802(17)260801(10)73H2300125(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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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 Expiration Date: 08/01/2026
• Device Model Number: IPN048826
• Device Catalogue Number: MAD100
• Device Lot Number: 73H2300125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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