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	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "open primary packaging.This was noted on 1 device." this occurred during inventory inspection.No patient inv olvement.
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 of the returned device revealed that the package was torn along the perforation of the package that is there to open it.There were no other defects observed with the package and it was confirmed to be completely sealed other than where it was opened along the perforation.It would not take much pressure to open the package along the perforation.A device history record review was performed and no relevant findings were identified.The reported complaint was confirmed based upon the sample received.Visual examination of the returned device revealed that the package was torn along the perforation of the package that is there to open it.There were no other defects observed with the package and it was confirmed to be completely sealed other than where it was opened along the perforation.It could not be determined when the package got opened, but it appears that the package most likely got caught on something during storage/shipping that caused it to partially open along the perforation.Teleflex will continue to monitor and trend on this reported issue.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "open primary packaging.This was noted on 1 device." this occurred during inventory inspection.No patient inv olvement.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16553942
• Report Number: 3003898360-2023-00433
• Device Sequence Number: 5088623
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: Health Professional
• Device Expiration Date: 05/03/2025
• Device Model Number: IPN048826
• Device Catalogue Number: MAD100
• Device Lot Number: 73E2200224
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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
• Patient Sex: Unknown