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

Catalog Number 60SP030

Device Problems Break (1069); Fracture (1260); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that "the collar cracked while the tube was changed¿.The event occurred at the patient¿s home during patient use.Adverse patient effects are unknown.The customer stated that no further information is available.

Manufacturer Narrative

D9 device returned to mfg: 1/3/2024.One device was received for investigation.The reported complaint was confirmed during visual inspection, which verified the device was broken at the flange.The investigation attributed this condition to the device having come into contact with a sharp object during reprocessing, or another issue related to handling.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Complaint data related to the reported issue will continue to be monitored.

• Brand Name: BIVONA SILICONE UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18217224
• MDR Text Key: 329130896
• Report Number: 1824231-2023-00000
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312000368
• UDI-Public: 15021312000368
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 60SP030
• Device Lot Number: 4209590
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1