MAUDE Adverse Event Report: SMITHS MEDICAL, INC. BIVONA CUSTOM TRACHEOSTOMY TUBE; JOH - TRACHEOSTOMY TUBE

Catalog Number CM1741N

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A report was received from the patent of an in-home pt stating the listed tracheostomy tube was found leaking at the cuff after two weeks in situ.No incident related medical sequela was reported.

Manufacturer Narrative

Customer has not yet returned the device to the mfr for device eval.When and if the device becomes available and is returned and evaluated, the mfr will file a f/u report detailing the results of the eval.

• Brand Name: BIVONA CUSTOM TRACHEOSTOMY TUBE
• Type of Device: JOH - TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL, INC.; gary IN
• Manufacturer (Section G): SMITHS MEDICAL, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4480265
• MDR Text Key: 5334246
• Report Number: 2183502-2014-01105
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Lay User/Patient
• Type of Report: Initial
• Report Date: 01/27/2015

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: Lay User/Patient
• Device Catalogue Number: CM1741N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2015
• Event Location: Home
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1