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

Model Number IPN049807

Device Problem Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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 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.".

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(b)(4), correction: initial mdr report (3004365956-2022-00050) was submitted in error and this report has been retracted.Please remove from your records and make a note of it.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
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15095073
• MDR Text Key: 304352137
• Report Number: 3004365956-2022-00050
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704645920
• UDI-Public: 14026704645920
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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 Model Number: IPN049807
• Device Catalogue Number: 1885
• Device Lot Number: 74A2002047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• 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