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

Model Number	IPN048826
Medical Device Problem Code	Unsealed Device Packaging (1444)
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).From the pictures attached it was confirmed the defect reported by the customer "packaging damage - device package".However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.Per dhr the product mad nasal with 3 ml syringe was manufactured on 08/02/2023.A total of (b)(4) pieces.Lot was released on 08/15/2023.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: "incomplete sealing of the packaging.The issue was identified at incoming inspection /inventory review.".
Event or Problem Description
It was reported that: "incomplete sealing of the packaging.The issue was identified at incoming inspection /inventory review.".
Additional Manufacturer Narrative
(b)(4).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 revealed that the sample was returned in its original packaging.However, the packaging was not sealed properly.The packaging was partially opened on one end.Non-conformance was previously initiated at the manufacturing site to further investigate this issue.The nonconformance found that during packaging, the syringe was dropped into the package and would occasionally get caught on the edge of the packaging.For this complaint sample, the syringe caught onto the edge of the packaging and moved it out of alignment which prevented it from being sealed properly.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 review investigation did not show issues related to complaint.The reported complaint of "packaging damage - device package" was confirmed based up-on the sample received.The sample was received with its original packaging partially opened as it was not sealed properly.Nonconformance was previously initiated at the manufacturing site to further investigate this issue.The nonconformance found that during packaging, the syringe was dropped into the package and would occasionally get caught on the edge of the packaging.For this complaint sample, the syringe caught onto the edge of the packaging and moved it out of alignment which prevented it from being sealed properly.Corrective actions were implemented to help prevent this issue from recurring.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: 21512826
• Report Number: 3003898360-2025-00196
• Device Sequence Number: 8021290
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown