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

Model Number	IPN049807
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint reported that: the patient needs to be aerosol inhaled after surgery, and is given aerosol inhalation according to the standard procedure.The mist output is small; immediate correction by hospital: replace with a new nebulizer.".
Event or Problem Description
The complaint reported that: the patient needs to be aerosol inhaled after surgery, and is given aerosol inhalation according to the standard procedure.The mist output is small; immediate correction by hospital: replace with a new nebulizer.".
Additional Manufacturer Narrative
(b)(4), correction: initial mdr report (3004365956-2022-00050) was submitted in error and this report has been retracted.Please remove from your records and make a note of it.

• Brand Name: HUDSON 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15095073
• Report Number: 3004365956-2022-00050
• Device Sequence Number: 14754530
• Product Code: CAF
• UDI-Device Identifier: 14026704645920
• UDI-Public: 14026704645920
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K930525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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
• Device Expiration Date: 01/22/2025
• Device Model Number: IPN049807
• Device Catalogue Number: 1885
• Device Lot Number: 74A2002047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown