MAUDE Adverse Event Report: TELEFLEX HUDSON ET TUBE, UNCUFFED, PED-SOFT, 2.5MM; ENDOTRACHEAL TUBE

Catalog Number T-30405

Device Problems Occlusion Within Device (1423); Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 07/25/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the tube appears to have a piece of plastic at the distal tip that is causing an occlusion.The alleged defect will not allow the suction catheter to pass completely through the endotracheal tube.The alleged defect was discovered during pre-test and prior to patient use.

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, uncuffed, ped-soft, 2.5, lot #01j1300088 was manufactured on 09/12/2013.The dhr investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes were required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect.At this time since the device sample is not available it is not possible to determine the source of the defect reported.The complaint cannot 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.If the device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend relating complaints.

• Brand Name: HUDSON ET TUBE, UNCUFFED, PED-SOFT, 2.5MM
• Type of Device: ENDOTRACHEAL TUBE
• Manufacturer (Section D): TELEFLEX; rtp NC
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4099015
• MDR Text Key: 21316134
• Report Number: 3003898360-2014-00647
• Device Sequence Number: 1
• Product Code: BSR
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: T-30405
• Device Lot Number: 01J1300088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SUCTION CATHETER