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

Catalog Number	60P045
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation results: two bivona uncuffed neonatal tracheostomy tube were received without their original packaging inside a (b)(6) bag.The samples were returned in a used condition and were accompanied by their certificates of decontamination.Visual inspection was performed on the samples at 12" under normal conditions of illumination.It was observed that the samples had splits in their shafts and had exposed wires inside of them.In addition, the inspection revealed some contaminations.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.The most probable root cause was that the damage occurred after the product left the manufacturing facility.
Event or Problem Description
It was reported that a smiths medical bivona uncuffed neonatal tracheostomy tracheostomy tube split through where the hub of the connector and shaft meet.The issue was discovered when the patient's mother was cleaning the tube she had just removed from the patient's airway.No adverse effects were reported.

• Brand Name: BIVONA
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8764157
• Report Number: 3012307300-2019-02136
• Device Sequence Number: 16718360
• Product Code: BTO
• UDI-Device Identifier: 15021312005769
• UDI-Public: 15021312005769
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2019

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: No Information
• Device Catalogue Number: 60P045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1