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

Model Number IPN048826

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the liquid does not come out of the syringe" there was no patient harm or consequence.

Manufacturer Narrative

(b)(4).The reported complaint of "occlusion - blockage/part stuck" was confirmed based upon the sample received.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 sample appears typical.The syringe was returned with the mad device.A functional inspection was performed on the returned device.The returned syringe was filled with water to test the atomization of the returned device.Upon testing, the device was not able to atomize properly.The water came out as a continuous stream.The device was sent to the manufacturing site for further analysis.The manufacturing site inspected the device and found no issues with the positioning of the insert (component that helps with atomization).It could not be determined what prevented the device from atomizing properly at this time.A device history record review was performed with no evidence to suggest a manufacturing related cause.Teleflex will continue to monitor and trend on this issue.

Event Description

It was reported that "the liquid does not come out of the syringe" there was no patient harm or consequence.

• Brand Name: MAD NASAL WITH 3 ML SYRINGE
• Type of Device: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18668185
• MDR Text Key: 334978571
• Report Number: 3003898360-2024-00213
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN048826
• Device Catalogue Number: MAD100
• Device Lot Number: 73H2200671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED