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

Catalog Number 0P055

Device Problems Material Discolored (1170); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Evaluation results: one used bivona tracheostomy tube was returned for investigation without its original packaging inside a (b)(4) bag.Visual inspection was performed at 12 inches under normal conditions of illumination to detect for any contamination on the unit.The investigator observed that the sample was contaminated with yellow spots.The substance was wiped away with a towel.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.Based on the information provided in the complaint description, it is most likely that the unit was contaminated once it left the manufacturing facility.

Event Description

It was reported that the lower shaft of the cannula was discolored and rough after two weeks of use.No reprocessing measures were taken.No patient injury or complications were reported in relation to this event.

• Brand Name: BIVONA
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8923203
• MDR Text Key: 156731675
• Report Number: 3012307300-2019-04222
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312005783
• UDI-Public: 15021312005783
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2019

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
• Device Operator: No Information
• Device Expiration Date: 09/11/2022
• Device Catalogue Number: 0P055
• Device Lot Number: 3502385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2018
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1