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

Model Number	IPN049807
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74g1801100 that belong to catalog number 1885 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The device history shows that the product was assembled and inspected according to our specifications.The customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If defective sample becomes available at a later date this complaint will be updated as applicable.
Event or Problem Description
Reported event: the doctor found the tube broken when using it on the patient.It was changed to a new one.There was no impact on the patient.
Additional Manufacturer Narrative
Qn# (b)(4).Report 3004365956-2023-00004 is being retracted.The report was submitted by mistake.Teleflex no longer owns the registration.
Event or Problem Description
Reported event: the doctor found the tube broken when using it on the patient.It was changed to a new one.There was no impact on the patient.

• Brand Name: MICRO MIST NEBULIZER W/ELONG
• 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: 16283306
• Report Number: 3004365956-2023-00004
• Device Sequence Number: 4758220
• Product Code: CAF
• UDI-Device Identifier: 14026704645920
• UDI-Public: 14026704645920
• 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: 07/15/2023
• Device Model Number: IPN049807
• Device Catalogue Number: 1885
• Device Lot Number: 74G1801100
• 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: 02/02/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2018
• 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