MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 670170

Device Problem Leak/Splash (1354)

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

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported that a cuff leak was discovered while in use with a patient.Leakage confirmed when product was withdrawn from patient and further tested.Customer states there was no patient injury.

Manufacturer Narrative

Device evaluated by manufacturer and h6.Health impact, and evaluation codes: updated.One device was received for investigation.The reported issue was confirmed during functional testing, which detected a leak in the sample device cuff.A review of the manufacturing device history records found no non-conformances, however the investigation attributed this observed condition to a manufacturing issue.This issue will continue to be monitored and further actions taken accordingly.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL PEDIATRIC
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16471489
• MDR Text Key: 310547753
• Report Number: 3012307300-2023-01940
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: 15021312006056
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 670170
• Device Catalogue Number: 670170
• Device Lot Number: 4201728
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian