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

Model Number	IPN048826
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The actual sample was not returned; however, the customer provided a photo for evaluation.A visual exam was performed on the photo and the failure mode was confirmed.A device history record review was performed and no relevant findings were identified.Without the actual device to evaluate the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "detached part from the syringe plunger." the customer was unable to answer any information regarding how the issue was resolved and what the status of the patient is.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).The customer returned a mad100 mad nasal with 3 ml syringe for investigation.Visual examination of the returned sample revealed that the plunger (black piece) on the inside of the syringe was detached.The nasal plug had stains that indicated the sample had been used.The detached plunger (black piece) on the syringe is indicative of the end user pulling too hard on the syringe.A device history record review was performed and no relevant findings were identified.The reported complaint was confirmed.The detached plunger (black piece) on the syringe is indicative of the end user pulling too hard on the syringe.Therefore, it appears that unintentional user error has caused this event.Teleflex will continue to monitor and trend on this issue.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "detached part from the syringe plunger." the condition of the patient was reported as "fine".No medical intervention was necessary.

• 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: 16600306
• Report Number: 3003898360-2023-00505
• Device Sequence Number: 20374625
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2025
• Device Model Number: IPN048826
• Device Catalogue Number: MAD100
• Device Lot Number: 73K2200838
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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: N/A.; N/A.
• Patient Sex: Unknown