MAUDE Adverse Event Report: SMITHS MEDICAL, INC. BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTREND PLUS SILICONE TRACHEOSTOMY TUBE; TRACHEOSTOMY TUBES

Catalog Number 60PFSS35

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A report was received stating that the device was in use for an unknown amount of time when the patient experienced discomfort from the tracheostomy tube.The device was replaced, and upon inspecting the removed tracheostomy tube, the device's internal wiring was observed exposed.No incident related medical sequela reported.

Manufacturer Narrative

Manufacturer completed the entire form.Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

• Brand Name: BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTREND PLUS SILICONE TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBES
• Manufacturer (Section D): SMITHS MEDICAL, INC.; gary IN
• Manufacturer (Section G): SMITHS MEDICAL, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4902270
• MDR Text Key: 15346587
• Report Number: 2183502-2015-00457
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944178
• 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: 06/30/2015

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: 60PFSS35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/30/2015
• 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