MAUDE Adverse Event Report: BIVONA; TRACHEOSTOMY

Model Number	3.5 MM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes neo/ped eyelet was torn open.Emergency trach change had to be done.
Additional 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
• Common Device Name: TRACHEOSTOMY
• MDR Report Key: 11645369
• Report Number: 3012307300-2021-02972
• Device Sequence Number: 2987955
• Product Code: BTO
• UDI-Device Identifier: 15021312000375
• UDI-Public: 15021312000375
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2025
• 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
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 05/09/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1