MAUDE Adverse Event Report: TELEFLEX HUDSON MASK, MEDIUM CONC, ELONG, ADULT; OXYGEN MASK

Catalog Number 1041

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the tubing is collapsing when it is on the pt.No report of a pt injury.

Manufacturer Narrative

A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect were not provided.The device history record was reviewed and showed that there were no issues related to the report complaint on the product or 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 on the incident.The customer complaint cannot be confirmed based only on the info provided, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident.However, current production was verified to identify any issue that can lead to the reported defect and no issues were found.If the device sample becomes available this investigation will be updated with the eval results.

• Brand Name: HUDSON MASK, MEDIUM CONC, ELONG, ADULT
• Type of Device: OXYGEN MASK
• Manufacturer (Section D): TELEFLEX; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3994430
• MDR Text Key: 4824229
• Report Number: 3004365956-2014-00257
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1041
• Device Lot Number: 02K1302188
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1