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  

Event Description

It was reported that "the liquid does not come out of the syringe and the device cannot used.Moreover, the nasal adaptor broke".The patient was reported as fine post the procedure.Associated complaints 3003898360-2024-00211.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The reported complaint of "occlusion - blockage/part stuck" was confirmed based upon the sample received.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.Visual examination of the returned device revealed that the nasal plug and distal tip were detached from the lumen tube.Although the device would be unable to function properly with the distal tip detached, an attempt to fire the device was made to see if anything was able to fire.The returned syringe was filled with water and then attached to the lumen tube to test for an occlusion of the returned device.Upon testing, the device was not able to fire any water.It appeared that there was an occlusion in the device.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.The qa inspector performs a random atomization test in the press process during the manufacturing of this device to help identify this issue, if it occurs, at the time of manufacturing.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 and the device cannot used.Moreover, the nasal adaptor broke".The patient was reported as fine post the procedure.Associated complaints 3003898360-2024-00211 and 3003898360-2024-00212.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18683373
• MDR Text Key: 335091600
• Report Number: 3003898360-2024-00212
• 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: 02/12/2024
• 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.