MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® PORTEX BIVONA FLEXTEND TTS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

Catalog Number 67PFSS40

Device Problems Crack (1135); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

Distributor reported on behalf of the product user's mother explaining that the silicone is cracking at the tracheostomy tube shaft, causing its internal wire to become exposed.The reporter explained that the tracheostomy tube had been reprocessed at least once.The reporter indicated that no adverse health effects were endured as a result of the reported event.

Manufacturer Narrative

One device was returned for product evaluation.Visual inspection confirmed the reported device issue.During functional testing, the shaft of the device was cut directly below the observed split.A microscope was used to measure both the inner and outer diameter of the tube directly below the split.Both measurements were found to be within manufacturing specification.The wall thickness was examined and it appeared to be consistent throughout the sample indicating that there was no short shot or void that contributed to the break in the silicone.Investigation could not determine the root cause of the shaft split; however, no evidence was found to suggest an intrinsic manufacturing defect.

• Brand Name: PORTEX® PORTEX BIVONA FLEXTEND TTS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• 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: 5498947
• MDR Text Key: 40280775
• Report Number: 2183502-2016-00529
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Catalogue Number: 67PFSS40
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• 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: Reuse
• Patient Sequence Number: 1