MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,NON-REBREATING W/O SFTY VENT,ELONG; MASK, OXYGEN, NON-REBREATHING

Catalog Number 41060

Device Problem Gas/Air Leak (2946)

Patient Problems Headache (1880); Dizziness (2194); No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

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

Customer complaint received as: whilst working on females patients, closely to the patient, there was a gas leak escaping from the mask.The caregiver inhaled nitrous oxide (kalinox) and therefore had dizziness and headache, she had to exit to the hallway to ask for help.The masks are not adapted to the faces of female patients, the joints are not sealed so there is a gas leak, gas inhaled by the caregiver.Clinical consequences: the patient did not receive the initially planned dose of gas.The department continues to use these masks while protecting themselves from possible gas leaks with a surgical mask and moving away from the patient.Additional information was received and it was reported both the patient and the caregiver are fine.It was also reported that given the current context, the main concern is that the leaking masks increase the risk for caregivers to be exposed to covid-19.

• Brand Name: HUDSON MASK,NON-REBREATING W/O SFTY VENT,ELONG
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 10071113
• MDR Text Key: 191576725
• Report Number: 3004365956-2020-00108
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 41060
• Device Lot Number: 74G1900426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• 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