MAUDE Adverse Event Report: TELEFLEX MEDICAL MICRO MIST NEBULIZER W/TEE; NEBULIZER (DIRECT PATIENT INTE

Model Number IPN049300

Device Problem No Flow (2991)

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

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported event: the doctor found no mist when using on patient.Then changed new one.No impact on patient.

Event Description

Reported event: the doctor found no mist when using on patient.Then changed new one.No impact on patient.

Manufacturer Narrative

Qn# (b)(4).Report 3004365956-2023-00005 is being retracted.It was submitted in err.

• Brand Name: MICRO MIST NEBULIZER W/TEE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16268946
• MDR Text Key: 308860005
• Report Number: 3004365956-2023-00005
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704627162
• UDI-Public: 14026704627162
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2023
• Device Model Number: IPN049300
• Device Catalogue Number: 1884
• Device Lot Number: 74G1800184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED