MAUDE Adverse Event Report: TELEFLEX HUDSON LARYNGECTOMY TUBE, LAR-A-JECT, 8.0; AIRWAY DEVICE - TRACHEAL TUBE

Catalog Number 5-11716

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/03/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that during installation of the device, the inflation line disconnected from the tube.The customer reports a loss of time to change the tube.No injury reported.

Manufacturer Narrative

The device sample was not returned for eval at the time of this report.

• Brand Name: HUDSON LARYNGECTOMY TUBE, LAR-A-JECT, 8.0
• Type of Device: AIRWAY DEVICE - TRACHEAL TUBE
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC ; 9194334965
• MDR Report Key: 3837584
• MDR Text Key: 18570314
• Report Number: 3003898360-2014-00143
• Device Sequence Number: 1
• Product Code: BSR
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5-11716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1