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

Model Number IPN049808

Device Problem Failure to Deliver (2338)

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

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported "the doctor found no mist during clinical inspection before using on patient".No patient involvement reported.

Manufacturer Narrative

(b)(4).The customer reported the nebulizer would not nebulize.The customer returned one nebulizer kit which includes a jet, jar, cap, tubing, and mask.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed the returned components appear typical with no observed defects or anomalies.Functional testing was performed on the returned sample.6cc of water was added to the returned nebulizer unit and the tubing was connected to an air flowmeter.The inlet pressure was set at 50psi and the flowrate was increased to 8lpm.During functional testing, a mist was produced coming from the chamber.No functional issues were found with the returned sample.Per the instruction label attached to the finished product, the directions for use instructs the user "if necessary, tab the device until it begins to nebulize".It also instructs the user "during treatment, periodically tab nebulizer to minimize residue volume".The reported complaint of the nebulizer not nebulizing could not be confirmed based on the sample received.During functional testing of the returned sample, the returned nebulizer was able to produce a mist coming from the chamber.A device history record review was performed on product code 1886; lot # 74f1802784 with no evidence to suggest a manufacturing related issue.Therefore, based on the functional testing, no issues were found with the returned sample.

Event Description

It was reported "the doctor found no mist during clinical inspection before using on patient".No patient involvement reported.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/ELONG
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11382180
• MDR Text Key: 234562683
• Report Number: 3004365956-2021-00062
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704645937
• UDI-Public: 14026704645937
• Combination Product (y/n): N
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2023
• Device Model Number: IPN049808
• Device Catalogue Number: 1886
• Device Lot Number: 74F1802784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1