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

Catalog Number	60SP030
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
D4 was corrected.**udi related data quality updates only**.

• Brand Name: BIVONA SILICONE UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
• Common Device Name: 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; lake forest, MN 60045 ; 2247062300
• MDR Report Key: 18217224
• Report Number: 1824231-2023-00000
• Device Sequence Number: 17822905
• Product Code: BTO
• UDI-Device Identifier: 15021312000368
• UDI-Public: (01)15021312000368(17)261009(10)4209590
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

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: Other
• Device Catalogue Number: 60SP030
• Device Lot Number: 4209590
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 02/22/2024; 02/22/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 03/20/2024; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown