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

Catalog Number 670180

Device Problems Leak/Splash (1354); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2017

Event Type  Injury  

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.

Event Description

It was reported that a portex® bivona® adult tts¿ tracheostomy tube leaked within a week of use.The issue was observed by the patient's family spontaneously.It was observed that the seams were perforated in the middle of the cuff.The cuff integrity was tested prior to use.The cuff had been filled with 7-8 ml of sterile water.Due to the issue, the patient went to the hospital for a tracheostomy tube change to a smaller size.No permanent injury was reported.See mfr: 3012307300-2017-00819, 3012307300-2017-00825, and 3012307300-2017-00826.

Event Description

It was further reported that cuff leak was initially noted due to the sound of the patient's respiration.The patient was brought to the hospital to receive a tracheostomy tube change and the patient received a different kind of tracheostomy tube.The patient was not admitted to hospital care and no permanent adverse effects to patient reported.

Manufacturer Narrative

The customer reported that four devices contributed to four reported events (one device per event).The customer returned one device for evaluation.It could not be determined which reported occurrence was associated with the returned device; therefore, the evaluation of the returned device will be used for the medwatches.The following mfr were submitted related to the evaluation: 3012307300-2017-00819, 3012307300-2017-00825, 3012307300-2017-00826, and 3012307300-2017-00827.One portex® 8.0mm bivona® adult tts¿ tracheostomy tube was returned for investigation.A review of the device history record was completed and no non-conformities were found.During visual and functional testing of the returned device a 1.34mm slice in the device cuff was found.It was determined that the observed cut was not due to a manufacturing issues as the devices are 100% leak tested prior to release.According to the device instructions for use (ifu), "guard against product damage by avoiding contact with sharp objects." investigation determined that the root cause of the observed cut was use of the device in a manner inconsistent from the device instructions for use.

Manufacturer Narrative

Corrected information: it was determined that the reported event date was unknown and not (b)(6) 2017 as previously reported.

• Brand Name: PORTEX® BIVONA® ADULT TTS¿ 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: 6477381
• MDR Text Key: 72284912
• Report Number: 3012307300-2017-00827
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006070
• UDI-Public: 15021312006070
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K913859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 10/24/2021
• Device Catalogue Number: 670180
• Device Lot Number: 3300505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other