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

Catalog Number 60PFSS40

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

One used sample returned for evaluation.Visual inspection found the wires near the distal tip had been deformed and the silicone was beginning to crack and expose the wire.Based on a scrap review, this type of defect has not been observed during manufacturing or assembly.Complaint history review did not find any other complaints of this nature.It appeared that the tips of the returned sample was crushed causing the wires to become permanently deformed which would stress the silicone causing it to crack.Simulation testing for this was carried out by using a tool to crush a sample and the wires deformed in a similar manner as the complaint sample.A review of manufacturing process found no instance where a device would incur this type of damage.This damage was visible to where it would easily be detected during inspection.The defect likely occurred during use, however unable to determine a definitive root cause.

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

• Brand Name: BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND PLUS SILICONE TRACHEOSTOMY TUBES
• Type of Device: 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: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4892631
• MDR Text Key: 6535695
• Report Number: 2183502-2015-00479
• 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: Unknown
• Type of Report: Initial,Followup
• Report Date: 07/01/2015

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: 60PFSS40
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2015
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/23/2015
• 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