MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER W/TEE & TUBING, SMALL VOLUME; NEBULIZER (DIRECT PATIENT INTE

Model Number	IPN049831
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
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 could not be conducted since the lot number of the device was not provided.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 that "we used to use the nebulizer ref 41745 in (b)(6) 2020.We have replaced this ref 41745 by the reference 41891.The sales representative informed me that the ref 41891 had no auto-occlusive valve.I provided this information to the head of the resuscitation department.Despite the fact that everyone is doing his best to provide all the information to the others, we faced an issue with a patient who was in the resuscitation department because the nurse was not enough aware of how to use the device.The patient "depressurized" because of this ignorance whilst changing the small reservoir, so the circuit opened and we provided resuscitation to the patient".It is unknown the type of intervention used on patient.Patient condition reported as "fine".

• Brand Name: HUDSON NEBULIZER W/TEE & TUBING, SMALL VOLUME
• Common Device Name: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11528203
• Report Number: 3004365956-2021-00091
• Device Sequence Number: 14744972
• Product Code: CAF
• UDI-Device Identifier: 14026704661517
• UDI-Public: 14026704661517
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: IPN049831
• Device Catalogue Number: 41891
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention