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

Catalog Number 41060

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The complaint was reported as: the customer alleges that there is a leak between the bag and the mask.The device was changed for another one.There was no consequence to the patient.

Manufacturer Narrative

A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record review showed that there were no issues related to this complaint neither on the product nor its components during the manufacture of the material.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident.The customer complaint cannot be confirmed based only on the information provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.If the defective sample becomes available this investigation will be updated with the evaluation results.

• Brand Name: HUDSON MASK, NON-REBREATHING W/O SFTY VENT, ELONG
• Type of Device: NON-REBREATHING MASK
• Manufacturer (Section D): TELEFLEX MEDICAL; nuevo laredo ; MX
• Manufacturer (Section G): TELEFLEX; ave. transformacion 5954; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3865238
• MDR Text Key: 17278341
• Report Number: 3004365956-2014-00060
• 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,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 41060
• Device Lot Number: 02E1202241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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