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

Model Number ZZ19KN70ZZZ006N

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: two tracheostomy tubes were returned for evaluation.The first sample was visually inspected and manipulated to search for any gaps or holes, and none were found.The second sample was also visually inspected and manipulated.The neck flange was adhered to the device, although a portion was found to not be fully flush with the neck flange section when manipulated.This confirms the reported event.A review of manufacturing records found no discrepancies or anomalies, and no trends relevant to this product line and complaint category were found during review of complaint data.

Event Description

It was reported that prior to use, it was noticed that the neck flange is not properly glued and gaps are able to be visualized.Customer reported that the gaps seem to be filled with "superslick".No patient involvement.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15204566
• MDR Text Key: 304974782
• Report Number: 3012307300-2022-15188
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517209983
• UDI-Public: 15019517209983
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZZ19KN70ZZZ006N
• Device Catalogue Number: ZZ19KN70ZZZ006N
• Device Lot Number: GA014238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1