MAUDE Adverse Event Report: COVIDIEN SHILEY; PED SPECIALIZED TRACH

Model Number MPED

Device Problem Sticking (1597)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported the obturator seems like it has more of a right angle and it is getting stuck in the tracheostomy tube.

Manufacturer Narrative

(b)(4).A dimensional test was performed to the received samples and all readings are within specification according to shiley custom tracheostomy tube template; therefore no failure mode was detected in the received sample, additionally all manufacturing controls were found acceptable and effective to detect the reported failure mode.

• Brand Name: SHILEY
• Type of Device: PED SPECIALIZED TRACH
• 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: 5430930
• MDR Text Key: 38581289
• Report Number: 2936999-2016-00148
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MPED
• Device Catalogue Number: MPED
• Device Lot Number: 15K0072JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1