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

Model Number	85P045
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to user interface.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
Event or Problem Description
It was reported that the pilot line of a pediatric 4.5 smiths medical bivona fome cuffed trach tube was found to have a slit in it while in situ in a pediatric patient.Slit was immediately next to the red pilot valve.This trach was new and inserted on nov 24th.No adverse patient effects were reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11129397
• Report Number: 3012307300-2021-00173
• Device Sequence Number: 4088964
• Product Code: JOH
• UDI-Device Identifier: 15021312007022
• UDI-Public: 15021312007022
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K913859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

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: Health Professional
• Device Expiration Date: 07/14/2025
• Device Model Number: 85P045
• Device Catalogue Number: 85P045
• Device Lot Number: 3998074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1