MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE

Catalog Number 60P045

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2016

Event Type  malfunction  

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.

Event Description

Distributor reported that device was in use with patient for 2 1/2 days before wear was found on the tube shaft.The patient was provided with a new tube.No adverse effects to patient.

Manufacturer Narrative

Date device investigation completed (07/11/2016).One used sample was returned for evaluation.Visual inspection of the device found no obvious abnormalities or defects.Physical manipulation of the shaft revealed tiny cracks in the silicone along the outside of the shaft, near the distal end.Magnified visual inspection of the inside of the shaft did not reveal any exposed wires on the inside.The outer diameter of the shaft was measured and was found to be within specification.A device history review of the reported lot number did not identify any anomalies in the raw materials or in the manufacturing processes.The manufacturing process for this device includes several inspections that would detect this type of damage and reject the product had the damage been present at that time.Investigation could not determine the root cause of the broken shaft; however, no evidence was found to suggest an intrinsic manufacturing defect.

• Brand Name: PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5727927
• MDR Text Key: 47489977
• Report Number: 2183502-2016-01191
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Catalogue Number: 60P045
• Device Lot Number: 2253050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability