MAUDE Adverse Event Report: COVIDIEN MALLINCKRODT; ESOPHAGEAL TRACHEAL AIRWAY

Model Number 5-18541

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that prior to use, there was an inflation/deflation issue with the cuff.There is no report of patient involvement and no report of serious injury or death associated with this event.

Manufacturer Narrative

(b)(4).The manufacturing guidelines and controls were reviewed and found effective to detect this type of failure mode.The reported malfunction is not related to the manufacturing process.

• Brand Name: MALLINCKRODT
• Type of Device: ESOPHAGEAL TRACHEAL AIRWAY
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5051322
• MDR Text Key: 25494604
• Report Number: 2936999-2015-00773
• Device Sequence Number: 1
• Product Code: CAO
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K875226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5-18541
• Device Catalogue Number: 5-18541
• Device Lot Number: 12L0688JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2012
• 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