MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	ZT17HN85ZSZ147NZ
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that there was a split in the foam of the cuff.This occurred after the bivona tracheostomy tube was re-processed for the first time.The tube was only a month old at the time of the incident.An emergent tracheostomy change was performed.No further complications were reported.
Additional Manufacturer Narrative
One 8.5mm custom tts foam cuff tracheostomy (trach) tube was returned for analysis.On arrival the silicone cuff that covered the foam was noted to be ripped/torn; exposing the foam underneath.The cuff was assessed under magnification; no manufacturing defects visible under magnification.The cuff was removed and the wall thickness was measured using thickness gage.The cuff thickness measurements were all within specification.Based on the evidence, the complaint is confirmed.However, the root cause is unknown.

• Brand Name: BIVONA TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7737069
• Report Number: 3012307300-2018-03214
• Device Sequence Number: 920652
• Product Code: JOH
• UDI-Device Identifier: 15019517121674
• UDI-Public: 15019517121674
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: ZT17HN85ZSZ147NZ
• Device Lot Number: DS016034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention