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

Qn# (b)(4).

Event Description

Customer complaint received as: whilst working on female 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.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.A functional test was performed and the sample was placed on a nebulizer compressor.During this time no leaking issues were detected.Air was flowing properly with no leaking issues.The device history record of batch number 74g1900426 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The unit functioned as intended.

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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 10071219
• MDR Text Key: 198094130
• Report Number: 3004365956-2020-00109
• 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,Followup
• Report Date: 04/28/2020

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
• Device Operator: No Information
• Device Catalogue Number: 41060
• Device Lot Number: 74G1900426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 05/27/2020
• Supplement Dates FDA Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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