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

Model Number IPN049831

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2021

Event Type  Injury  

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 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
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 11528203
• MDR Text Key: 241033168
• Report Number: 3004365956-2021-00091
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704661517
• UDI-Public: 14026704661517
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN049831
• Device Catalogue Number: 41891
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention