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

Model Number	IPN049808
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported "the doctor found no mist during clinical inspection before using on patient".No patient involvement reported.
Event or Problem Description
It was reported "the doctor found no mist during clinical inspection before using on patient".No patient involvement reported.
Additional 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
• Common Device Name: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11382219
• Report Number: 3004365956-2021-00068
• Device Sequence Number: 14475305
• Product Code: CAF
• UDI-Device Identifier: 14026704645937
• UDI-Public: 14026704645937
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K930525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1