MAUDE Adverse Event Report: BIVONA; TRACHEOSTOMY

Model Number 3.5 MM

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Airway Obstruction (1699)

Event Date 03/04/2021

Event Type  malfunction  

Event Description

Information received a smiths medical tracheostomy|silicone - bivona tubes neo/ped eyelet was torn open.Emergency trach change had to be done.

Manufacturer Narrative

Other, other text: one picture and one sample was returned for evaluation.A small split was observed in the middle of one eyelet in the picture.During inspection of the returned sample, a cut in the flange corner could be seen confirming the complaint.Based on the analysis conducted in the sample provided, the failure of broken flange was confirmed.Therefore, according to on pfmea (rmd-10001943) and ifu (10018858-001) the occurrence of this failure condition could be caused by: velcro or metal clips from tracheostomy holders which may have sharp edges which can come into contact with eyelets and compromise the product integrity.Molding related process.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.

• Brand Name: BIVONA
• Type of Device: TRACHEOSTOMY
• MDR Report Key: 11645369
• MDR Text Key: 244843408
• Report Number: 3012307300-2021-02972
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312000375
• UDI-Public: 15021312000375
• Combination Product (y/n): N
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.5 MM
• Device Catalogue Number: 60SP035
• Device Lot Number: 4026679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1