MAUDE Adverse Event Report: COVIDIEN SHILEY; 3.0 NEONATAL TRACHEOSTOMY TUBE

Catalog Number 3.0 NEO

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Patient Involvement (2645)

Event Date 06/09/2014

Event Type  malfunction  

Manufacturer Narrative

The reported "human factr-usability" failure mode was not confirmed in the received sample.The batch record for the returned sample was reviewed and all quality requirements were found effective to detect the reported failure mode.(b)(4).

Event Description

It was reported by a customer in (b)(6) that the 3.0 neo neonatal tracheostomy tube obturator was too stiff for insertion.Although requested, there is no available information regarding patient involvement, or how the unit was found to be too stiff.

Manufacturer Narrative

The device is expected to be returned and evaluated.However, it has not been yet received by covidien.(b)(4).

• Brand Name: SHILEY
• Type of Device: 3.0 NEONATAL TRACHEOSTOMY TUBE
• Manufacturer (Section D): COVIDIEN; avenida henequen; juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; 1181 parque industrial salvarcar; juarez, chihuahua ; MX
• Manufacturer Contact: denise braxton ; 6135 gunbarrel ave.; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4002553
• MDR Text Key: 12471187
• Report Number: 2936999-2014-00624
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K945513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3.0 NEO
• Device Lot Number: 110901347X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2014
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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