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

Device Problem Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Date of event is unknown, no information has been provided to date.D4 and h4 are unknown, no product information has been provided to date.

Event Description

It was reported that the trach tube cuff has popped during the sterilization process.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.Customer reported the event involve item number 67pfssxx.Customer tried to troubleshoot this issue and they are following the ifu and directions for sterilization.Customer reports the product has no lot number.One trach tube sample has been identified and the identification of other samples its pending.

Manufacturer Narrative

One used device was received for investigation.The reported issue was confirmed during visual inspection, which identified a rupture in the proximal end of the airway balloon, near the connector.No product lot number was provided, therefore, no review of manufacturing device history records could be conducted.Based on the available information, the investigation confirmed the reported complaint.The observed rupture was determined to be consistent with damage caused by improper handling of the device balloon, however the investigation could not identify a definite root-cause.A notification of this complaint's details was provided to production personnel and complaint trends will be monitored with actions taken as needed.The customer was provided with a copy of the cautions for handling section of the device instructions for use.

• 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: 16293578
• MDR Text Key: 308781174
• Report Number: 3012307300-2023-00848
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1