MAUDE Adverse Event Report: TELEFLEX HUDSON ET TUBE, CF, 4.0MM; ENDOTRACHEAL TUBE

Catalog Number 5-10108

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the incremental marking on the endotracheal tube (4.0mm) are not accurate.The reported issue was detected prior to pt use and during pre-testing.No pt injury.

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.Per dhr (device history record) the product et tube, cf, 4.0, lot #01d1300174 was mfg on 04/17/2013.The dhr investigation did not show issues related to complaint.A document assessment was conducted and no changes were required.The complaint can not be confirmed since the sample was not available for investigation, therefore, it is not possible to determine the root cause for the defect reported and a corrective action for it.Teleflex will continue to monitor and trend relating complaints.

• Brand Name: HUDSON ET TUBE, CF, 4.0MM
• Type of Device: ENDOTRACHEAL TUBE
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer Contact: margie burton, rn, regulatory af ; p.o. boc 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3818504
• MDR Text Key: 17996660
• Report Number: 3003898360-2014-00232
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5-10108
• Device Lot Number: 01D1300174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1