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

Catalog Number FT13JN50NSF074N

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A report was received stating that the flange of a tracheostomy tube tore after an unknown amount of time in use.No permanent adverse effects to patient reported.

Manufacturer Narrative

The suspect device was returned for evaluation.Upon visual inspection, the neck flange was found split away from the tube.A split was also found at the swivel connector.The physical characteristics of the split are consistent with damage caused by a sharp object coming into contact with the product.Manufacturing review results confirmed all operations and inspections were conducted and device was manufactured according to standard procedure.If the split had been there prior to product release, it would have been detected and the product would have been scrapped.No evidence was found to suggest the reported event was caused by an intrinsic defect in the product.

• Brand Name: BIVONA CUSTOM TTS FLEXTEND 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: 4390696
• MDR Text Key: 5434077
• Report Number: 2183502-2014-01023
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/30/2014

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: Health Professional
• Device Catalogue Number: FT13JN50NSF074N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: No
• 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