MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM; NEBULIZER (DIRECT PATIENT INTE

Model Number	IPN049826
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Event or Problem Description
It was reported "involved a (b)(6) year-old female patient - weight (b)(6) kg.Patient came to the hospital to get her specific nebulizer.During the setting up of the kit, there was none or almost no treatment mist".New device used.No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM
• Common Device Name: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12646757
• Report Number: 3004365956-2021-00288
• Device Sequence Number: 13776975
• Product Code: CAF
• UDI-Device Identifier: 14026704661463
• UDI-Public: 14026704661463
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K895231
• 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
• Report Date (Section B): 09/24/2021

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: No Information
• Device Expiration Date: 02/04/2026
• Device Model Number: IPN049826
• Device Catalogue Number: 41755
• Device Lot Number: 74B2100324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1