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 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

(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.

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 sample was received for evaluation.A visual exam was performed and a foreign particle was found in the nebulizer jar.A device history record review was performed and no relevant findings were identified.Based on the visual exam the complaint was confirmed.A non-conformance was opened to address this issue.

• 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: 11382219
• MDR Text Key: 234107570
• Report Number: 3004365956-2021-00068
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2024
• Device Model Number: IPN049808
• Device Catalogue Number: 1886
• Device Lot Number: 74B1900530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Initial Date Manufacturer Received: 02/07/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1