MAUDE Adverse Event Report: COVIDIEN MALLINCKRODT; TRACHEAL TUBE

Model Number 18770

Device Problem Application Program Problem (2880)

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

Event Date 02/25/2015

Event Type  malfunction  

Event Description

It was reported that during prior to use tests, the physician found the tracheal tube inflation and deflation process could not be done smoothly.There was no patient involvement.There is no report of death or serious injury associated with this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).One tracheal tube was received for evaluation.A visual inspection was performed, and it was observed that the inflation line was not assembled properly into the tube lumen causing a collapse.An inflation/deflation test was performed by using a 25cc syringe of air applied to the cuff.It was observed that the inflation and deflation was hard to complete.The customer reported malfunction was verified.

• Brand Name: MALLINCKRODT
• Type of Device: TRACHEAL TUBE
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; juarez, chihuahua ; MX
• Manufacturer Contact: denise braxton ; 6135 gunbarrel avenue; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4612638
• MDR Text Key: 18547071
• Report Number: 2936999-2015-00243
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18770
• Device Catalogue Number: 18770
• Device Lot Number: 14H0452JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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