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

Model Number	IPN049300
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported event: the doctor found no mist when using on patient.Then changed new one.No impact on patient.
Event or Problem Description
Reported event: the doctor found no mist when using on patient.Then changed new one.No impact on patient.
Additional Manufacturer Narrative
Qn# (b)(4).Report 3004365956-2023-00005 is being retracted.It was submitted in err.

• Brand Name: MICRO MIST NEBULIZER W/TEE
• Common Device Name: 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
• Report Number: 3004365956-2023-00005
• Device Sequence Number: 6474877
• Product Code: CAF
• UDI-Device Identifier: 14026704627162
• UDI-Public: 14026704627162
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K930525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2018
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown