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

Catalog Number FT16HN35NGE906N

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a portex® bivona® custom flextend¿ tts¿ neonatal and pediatric tracheostomy tube was tearing at the neck.The incident occurred during insertion and discovered during use.The incident was observed by the patient's family and home health nursing.The tracheostomy tube was used 2-3 times and sterilized by placing in boiled water.It was noted that dale tracheostomy tube ties were used to hold the device.The tracheostomy tube was changed to a new tube when the issue occurred.No patient injury was reported.See mfr: 3012307300-2017-00271 and 3012307300-2017-00273.

Manufacturer Narrative

The customer reported that three devices contributed to three reported events (one device per event).The customer returned three devices for evaluation.It could not be determined which device was associated with which reported occurrence; therefore, the evaluation of the three returned devices will be used for the medwatch.Three used bivona® customized tracheostomy tubes were returned for investigation.The devices were received without their original packaging.Visual inspection of the devices found varying degrees cuts/tears on the section of the shaft that connects to the connector.Additionally, it was noted that the wire was exposed on some of the shafts.The observed cuts/tears were found to be consistent with the device being disconnected from the ventilator circuit by pulling or twisting motion rather than using the provided wedge.Investigation determined that the root cause of the cuts/tears was the device being used in a manner inconsistent from the instructions for use.

• Brand Name: PORTEX® BIVONA® CUSTOM FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6283436
• MDR Text Key: 65958140
• Report Number: 3012307300-2017-00272
• 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: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FT16HN35NGE906N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Weight: 8